Combination Chemotherapy Followed By Stem Cell Transplant in Treating Young Patients With Progressive or Relapsed Anaplastic Large Cell Lymphoma | Not Recruiting
Combination Chemotherapy Followed By Stem Cell Transplant in Treating Young Patients With Progressive or Relapsed Anaplastic Large Cell Lymphoma

Trial Source

There is no location for this trial

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Health Conditions
  • Lymphoma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Not Recruiting
Recruitment Status
NCT00317408
Primary Trial ID Number
Summary
RATIONALE: Giving combination chemotherapy and total-body irradiation before a peripheral stem cell transplant that uses the patient's or a donor's stem cells, helps stop both the growth of cancer cells and the patient's immune system from rejecting the stem cells. When the stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy and total-body irradiation followed by a stem cell transplant may be an effective treatment for anaplastic large cell lymphoma. PURPOSE: This clinical trial is studying how well combination chemotherapy followed by stem cell transplant works in treating young patients with progressive or relapsed anaplastic large cell lymphoma.
Research Details
  • OBJECTIVES: Primary - Improve the probability of event-free survival in children and adolescents with early progression of anaplastic large cell lymphoma (ALCL) and/or relapse of ALCL with CD3-positive immunophenotype treated with reinduction combination chemotherapy followed by allogeneic or autologous stem cell transplantation. - Determine whether a conditioning regimen comprising carmustine, etoposide phosphate, cytarabine, and melphalan (BEAM) (without total body irradiation) for autologous stem cell transplantation is an effective treatment for patients with relapsed CD3-negative ALCL occurring after the intensive phase of treatment. - Determine the impact of vinblastine in patients with late relapse of CD3-negative ALCL who have not received vinblastine during frontline therapy. Secondary - Determine overall survival and treatment-related mortality in patients treated with these regimens. - Determine acute and long-term toxicity in patients treated with these regimens. - Determine the rate of acute and chronic graft-vs-host disease in patients treated with allogeneic stem cell transplantation. OUTLINE: This is a multicenter, prospective, nonrandomized study. Patients are stratified according to time from initial diagnosis to progression/relapse, immunophenotype of lymphoma cells (CD3-positive + vs CD3-negative), stem cell donor availability (matched sibling donor vs 9/10 or 10/10 matched unrelated donor), and vinblastine during frontline therapy (yes vs no). - Group 1 (early progression): Patients receive 1 course of ICM chemotherapy followed by 1 course of ICI chemotherapy. - ICM chemotherapy: Patients receive methotrexate, cytarabine, and prednisolone intrathecally (IT) on day 1, mitoxantrone hydrochloride IV over 5 hours on days 1 and 2, carboplatin IV continuously on days 2-5 and ifosfamide IV continuously on days 2-6. - ICI chemotherapy: Patients receive methotrexate, cytarabine, and prednisolone intrathecally on day 1, idarubicin IV over 4 hours on days 1 and 2, carboplatin IV continuously on days 2-5, and ifosfamide IV continuously on days 2-6. Patients then proceed to allogeneic stem cell transplantation. - Group 2 (relapsed disease and CD3-positive lymphoma cells): Patients are stratified according to stem cell donor availability (yes vs no). - Available donor: Patients receive 2 courses of CC chemotherapy and then proceed to allogeneic stem cell transplantation. - Unavailable donor : Patients receive 2 courses of CC chemotherapy comprising dexamethasone orally or IV on days 1-5, vindesine IV on day 1, cytarabine IV over 3 hours on days 1 and 2, etoposide phosphate IV over 2 hours on days 3-5, and methotrexate, cytarabine, and prednisolone IT on day 5. Patients then receive 1 course of CVA chemotherapy comprising oral lomustine on day 1, vinblastine IV on days 1, 8, 15, and 22, and cytarabine IV over 1 hour on days 1-5. Patients undergo leukapheresis for collection of autologous peripheral blood stem cells after the first and/or second course of CC chemotherapy. Patients then proceed to autologous stem cell transplantation. - Group 3 (relapsed disease, CD3-negative immunophenotype, and received vinblastine during frontline therapy): Patients receive 2 courses of CC chemotherapy and 1 course of CVA chemotherapy as described above. Patients undergo leukapheresis for collection of autologous peripheral blood stem cells (PBSC) after the first and/or second course of CC chemotherapy. Patients then proceed to autologous stem cell transplantation. - Group 4 (late relapse, CD3-negative immunophenotype, and did not receive vinblastine during frontline therapy): Patients receive vinblastine IV once weekly for 24 months. Patients with disease progression during or relapsed disease after vinblastine therapy undergo treatment as in group 3. - Autologous stem cell transplantation (SCT): Patients receive a conditioning regimen comprising carmustine IV over 1 hour on day -7, etoposide phosphate IV over 1 hour and cytarabine IV over 30 minutes on days -6 to -3, and melphalan IV over 15 minutes on day -2. Patients undergo autologous SCT on day 0. - Allogeneic SCT: Beginning 4-6 weeks after the start of the last chemotherapy course, patients receive 1 of the following conditioning regimens based on age: - Patients > 2 years of age undergo total body irradiation on days -7 to -5 and receive thiotepa IV over 1 hour on day -4 and etoposide IV over 4 hours on day -3. Patients undergo allogeneic SCT on day 0. - Patients ≤ 2 years of age receive oral busulfan 4 times daily on days -8 to -5, thiotepa IV over 1 hour twice on day -4, and etoposide phosphate IV over 4 hours on day -3. Patients undergo allogeneic SCT on day 0. Patients undergoing SCT from an unrelated donor also receive antithymocyte globulin IV over 4 hours on days -3 to -1. All patients receive graft-versus-host (GVHD) prophylaxis as described below. - GVHD prophylaxis: GVHD prophylaxis is administered as per donor status. - Matched sibling donor: Patients receive cyclosporine IV over 2 hours or orally on day -1 to 60 followed by a taper. - 10/10 or 9/10 matched unrelated donor: Patients receive cyclosporine IV over 2 hours or orally on days -1 to 100 followed by a taper, methotrexate IV on days 1, 3, and 6, and leucovorin calcium IV on days 2, 4, and 7. - Mismatched donor: Patients do not receive GVHD prophylaxis, however, CD3-positive lymphocytes are extracted from donor stem cells. After completion of study treatment, patients are followed periodically for 10 years. PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.
Phase
N/A
Study Design
Allocation: Non-Randomized, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Biological : anti-thymocyte globulin, Drug : busulfan, Drug : carboplatin, Drug : carmustine, Drug : cyclosporine, Drug : cytarabine, Drug : dexamethasone, Drug : etoposide phosphate, Drug : idarubicin, Drug : ifosfamide, Drug : leucovorin calcium, Drug : lomustine, Drug : melphalan, Drug : methotrexate, Drug : mitoxantrone hydrochloride, Drug : prednisolone, Drug : thiotepa, Drug : vinblastine sulfate, Drug : vindesine, Procedure : allogeneic hematopoietic stem cell transplantation, Procedure : autologous hematopoietic stem cell transplantation, Procedure : peripheral blood stem cell transplantation, Radiation : total-body irradiation

Study Arm Groups : , , , , , , , , , , , , , , , , , , , , , ,

Intervention Type
See Interventions above
Primary Outcome Measures
  • Event-free survival as measured by the Kaplan-Meier method; null
Secondary Outcome Measures
  • Proportion of patients who are treated on protocol among all patients who meet the inclusion criteria; null; Overall survival; null; Acute and long term toxicity; null; Rate of acute and chronic graft-vs-host disease in patients with allogeneic stem cell transplantation; null; Treatment related mortality; null
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
N/A - 21 Years
Who Can Participate
Patients
Number of Participants
96
Participant Inclusion Criteria
  • DISEASE CHARACTERISTICS:
  • - Histologically or cytologically confirmed anaplastic large cell lymphoma (ALCL)
  • - Progressive disease OR first relapse
  • - No second or subsequent relapse of ALCL
  • - Slides available for national central pathology review
  • - Availability of 1 of the following (for allogeneic stem cell transplantation only):
  • - HLA-identical matched sibling donor
  • - 10/10 HLA-matched nonsibling donor (related or unrelated)
  • - 9/10 HLA-matched nonsibling donor (1-antigen-mismatched related or unrelated
  • donor)
  • - < 9/10 HLA-mismatched donor (related or unrelated)
  • - Stem cells may be obtained from unmanipulated bone marrow or peripheral
  • blood stem cells after filgrastim (G-CSF) stimulation
  • PATIENT CHARACTERISTICS:
  • - Not pregnant or nursing
  • - Negative pregnancy test
  • - Fertile patients must use effective contraception
  • - Adequate hepatic, renal, and cardiac function
  • - No HIV infection or AIDS
  • - No severe immunodeficiency
  • - No other prior malignancy
  • - No pre-existing disease or condition prohibiting study treatment
  • PRIOR CONCURRENT THERAPY:
  • - At least 2 months since prior chemotherapy or radiotherapy
  • - No significant pretreatment for first relapse
  • - No prior organ transplantation
  • - No concurrent participation in another clinical trial
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Addenbrooke's Hospital
Cambridge
England
CB2 2QQ
GSK Investigational Site
London
WC1N 3JH
Nottingham University Hospitals NHS Trust
Nottingham
NG7 2UH
St. James University Hospital
Leeds
LS9 7TF
Southampton General Hospital
Southampton
England
SO16 6YD
Site: 44
Sheffield
S10 2TH
Birmingham
West Midlands
B4 6NH
Research Site
Sutton
Surrey
SM2 5PT
Leicester Royal Infirmary
Leicester
England
LE1 5WW
GSK Investigational Site
Liverpool
L12 2AP
Royal Belfast Hospital for Sick Children
Belfast
Northern Ireland
BT12 6BE
University Hospital of Wales
Cardiff
Wales
CF14 4XW
Royal Hospital for Sick Children
Glasgow
Glasgow City
G3 8SJ
Institute of Child Health at University of Bristol
Bristol
England
BS2 8AE
Oxford Radcliffe Hospital
Oxford
England
0X3 9DU
Pfizer Investigational Site
London
W1T 3AA
Royal Hospital for Sick Children
Edinburgh
Scotland
EH9 1LF
Royal Manchester Children's Hospital
Manchester
England
M27 4HA
Royal Victoria Infirmary
Newcastle-Upon-Tyne
England
NE1 4LP
Royal Aberdeen Children's Hospital
Aberdeen
Scotland
AB25 2ZG
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Austria, Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Poland, Sweden, Switzerland, United Kingdom
Scientific Title
Treatment Protocol for Relapsed Anaplastic Large Cell Lymphoma of Childhood and Adolescence
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CDR0000466639
Sponsor(s)
European Inter-Group Co-operation on Childhood Non-Hodgkin Lymphoma
Key Dates

Recruitment Start Date

Apr 2004

Recruitment End Date
Date Not Available
Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

19 Apr 2006

Last Updated

16 Sep 2013