Combination Chemotherapy Followed By Stem Cell Transplant in Treating Young Patients With Progressive or Relapsed Anaplastic Large Cell Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00317408
First received: April 19, 2006
Last updated: September 16, 2013
Last verified: June 2007
  Purpose

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.


Condition Intervention
Lymphoma
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 Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Treatment Protocol for Relapsed Anaplastic Large Cell Lymphoma of Childhood and Adolescence

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival as measured by the Kaplan-Meier method [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients who are treated on protocol among all patients who meet the inclusion criteria [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Acute and long term toxicity [ Designated as safety issue: Yes ]
  • Rate of acute and chronic graft-vs-host disease in patients with allogeneic stem cell transplantation [ Designated as safety issue: No ]
  • Treatment related mortality [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: April 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317408

  Show 98 Study Locations
Sponsors and Collaborators
European Inter-Group Co-operation on Childhood Non-Hodgkin Lymphoma
Investigators
Study Chair: Alfred Reiter, MD Kinderklinik
Investigator: Denise Williams, MD Cambridge University Hospitals NHS Foundation Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00317408     History of Changes
Other Study ID Numbers: CDR0000466639, EICNHL-ALCL-RELAPSE, AIEOP-EICNHL-ALCL-RELAPSE, BFM-EICNHL-ALCL-RELAPSE, BSPHO-EICNHL-ALCL-RELAPSE, DCOG-EICNHL-ALCL-RELAPSE, NOPHO-EICNHL-ALCL-RELAPSE, PPLLSG-EICNHL-ALCL-RELAPSE, SFCE-EICNHL-ALCL-RELAPSE, SHOP-EICNHL-ALCL-RELAPSE, CCLG-NHL-2006-01, EU-205118, EU-20618, EUDRACT-2005-003321-57
Study First Received: April 19, 2006
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
anaplastic large cell lymphoma
recurrent childhood anaplastic large cell lymphoma
stage III childhood anaplastic large cell lymphoma
stage IV childhood anaplastic large cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Antilymphocyte Serum
Busulfan
Cyclosporins
Cyclosporine
Cytarabine
Melphalan
Methotrexate
Thiotepa
Carmustine
Ifosfamide
Isophosphamide mustard
Lomustine
Etoposide phosphate
Dexamethasone
Etoposide
Idarubicin
Prednisolone
Methylprednisolone Hemisuccinate
Mitoxantrone
Vinblastine

ClinicalTrials.gov processed this record on July 31, 2014