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

Sponsored by:	European Inter-Group Co-operation on Childhood Non-Hodgkin Lymphoma
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00317408

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	Drug: 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 Drug: vindesine Procedure: allogeneic hematopoietic stem cell transplantation Procedure: autologous hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Procedure: total-body irradiation

Condition

Intervention

Lymphoma

Drug: 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
Drug: vindesine
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: autologous hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Procedure: total-body irradiation

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Ifosfamide Carboplatin Cytarabine Cytarabine hydrochloride Etoposide Idarubicin Idarubicin hydrochloride Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Methotrexate Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Mitoxantrone hydrochloride Mitoxantrone Carmustine Melphalan Thiotepa Cyclosporin Cyclosporine Etoposide phosphate Calcium gluconate Melphalan hydrochloride Sarcolysin Lomustine Vinblastine Vinblastine sulfate Busulfan Vindesine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized
Official Title:	Treatment Protocol for Relapsed Anaplastic Large Cell Lymphoma of Childhood and Adolescence

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

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

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00317408
Health Authority:	Unspecified

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

Study placed in the following topic categories:

Dexamethasone
Melphalan
Cyclosporine
Clotrimazole
Methylprednisolone
Miconazole
Lomustine
Vindesine
Leucovorin
Vinblastine
Prednisolone acetate
Cyclosporins
Etoposide phosphate
Lymphoma, large-cell
Lymphoma, B-Cell

Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Methotrexate
Etoposide
Lymphoma
Cytarabine
Dexamethasone acetate
Methylprednisolone Hemisuccinate
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Carmustine
Tioconazole
Methylprednisolone acetate
Carboplatin
Recurrence

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Antibiotics, Antineoplastic
Hormones
Sensory System Agents
Vitamins

Therapeutic Uses
Antifungal Agents
Abortifacient Agents
Analgesics
Micronutrients
Alkylating Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Vitamin B Complex
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Growth Substances
Mitosis Modulators
Gastrointestinal Agents

ClinicalTrials.gov processed this record on January 16, 2009