Donor Stem Cell Transplant Followed By Donor White Blood Cell Infusions in Treating Young Patients With Hematologic Cancer

NCT00301860 | Terminated DMC

• 3 other identifiers: CDR0000462439UCSF-02164UCSF-H10216-21819-03
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Giving chemotherapy before a donor peripheral blood stem cell transplant helps stop both the growth of cancer cells and the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving chemotherapy, such as fludarabine and melphalan, and antithymocyte globulin before transplant and cyclosporine and methotrexate after transplant may stop this from happening. PURPOSE: This clinical trial is studying how well donor stem cell transplant, using low-dose chemotherapy and antithymocyte globulin, followed by donor white blood cell infusions work in treating young patients with hematologic cancer.

Conditions

Leukemia; Lymphoma

Keywords

childhood acute lymphoblastic leukemia in remission; childhood acute myeloid leukemia in remission; recurrent childhood acute lymphoblastic leukemia; recurrent childhood acute myeloid leukemia; recurrent childhood small noncleaved cell lymphoma; juvenile myelomonocytic leukemia; chronic phase chronic myelogenous leukemia; accelerated phase chronic myelogenous leukemia; relapsing chronic myelogenous leukemia; recurrent childhood large cell lymphoma; recurrent childhood lymphoblastic lymphoma; recurrent/refractory childhood Hodgkin lymphoma; childhood chronic myelogenous leukemia

Interventions

anti-thymocyte globulin BIOLOGICAL

filgrastim BIOLOGICAL

therapeutic allogeneic lymphocytes BIOLOGICAL

cyclosporine DRUG

fludarabine phosphate DRUG

melphalan DRUG

methotrexate DRUG

allogeneic hematopoietic stem cell transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Diagnosis of one of the following hematopoietic malignancies: * Acute lymphoblastic leukemia or myeloid leukemia with \< 30% blasts in the bone marrow * Juvenile myelomonocytic leukemia * Chronic myelogenous leukemia in chronic or accelerated phase * Relapsed non-Hodgkin's or Hodgkin's lymphoma in at least partial remission * Considered at high risk (\> 30%) of toxic death with standard hematopoietic stem cell transplantation (HSCT), as indicated by at least one of the following: * Creatinine \> 1.5 times normal OR creatinine clearance \< 70 mL/min OR tubular damage that is not corrected by cessation of chemotherapy * DLCO \< 60% of predicted OR history of prior intubation due to lung disease (intubation for surgery excluded) * Shortening fraction \< 30% * History of disseminated fungal infection during chemotherapy OR currently receiving antifungal agents OR history of ≥ 2 septic episodes (confirmed by cultures) that required ICU support * Patients with improving fungal or other infections eligible * Improving infection is defined as confirmed negative cultures on 2 separate occasions, at least 1 week apart, and/or stable or improving imaging studies (e.g., CT scan) of the infected site * Two imaging studies taken at least 2 weeks apart must show stable or improved disease * History of stroke or abnormal MRI/MRA OR leukoencephalopathy OR seizures that are not fully controlled with anticonvulsants (\> 2 episodes of seizures in the preceding year or 1 episode of status epilepticus in a patient who is receiving anticonvulsant therapy) * History of prior significant bleeding (e.g., pulmonary, CNS, or gastrointestinal) OR history of a clotting disorder as manifested by prior significant thromboses (e.g., superior vena cava, inferior vena cava, or femoral vein) * Failed conventional therapies and not eligible for myeloablative protocols * May have failed prior conventional HSCT * No active CNS leukemia * Unrelated or related donor available, meeting the following criteria: * Matched for at least 7/8 loci by high-resolution typing * One mismatch at A, B, or C loci allowed * Fully matched at DRB1 locus PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% * No active/progressing viral, bacterial, protozoal, or fungal infection * Transaminases ≤ 5 times normal (except in the presence of autoimmune liver disease) * Shortening fraction ≥ 25% * DLCO ≥ 40% OR pulse oximetry ≥ 85% on room air * Glomerular filtration rate ≥ 40 mL/min PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior prolonged intensive chemotherapy (\> 3 years of therapy or ≥ 3 different chemotherapeutic protocols) allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Leukemia; Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Burkitt Lymphoma; Leukemia, Myelomonocytic, Juvenile; Leukemia, Myeloid, Chronic-Phase; Leukemia, Myeloid, Accelerated Phase; Dendritic Cell Sarcoma, Interdigitating; Recurrence

Interventions

Antilymphocyte Serum; Filgrastim; Cyclosporine; fludarabine phosphate; Melphalan; Methotrexate; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Leukemia, Myeloid; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Histiocytic Disorders, Malignant; Histiocytosis

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Biljana Horn, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2006
• First Posted: March 13, 2006
• Study Start: January 1, 2003
• Primary Completion: March 1, 2007
• Study Completion: November 1, 2007
• Last Updated: July 15, 2013

Record last verified: 2013-07

Locations

US (1)