NCT00024128

Brief Summary

RATIONALE: Donor peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Treatment with donor white blood cells may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of donor peripheral stem cell transplantation followed by infusions of donor white blood cells in treating patients who have AIDS-related lymphoma.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2001

Shorter than P25 for phase_2 lymphoma

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2001

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 21, 2003

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

1.6 years

First QC Date

September 13, 2001

Last Update Submit

February 1, 2016

Conditions

Lymphoma

Keywords

AIDS-related peripheral/systemic lymphomaHIV-associated Hodgkin lymphoma

Interventions

anti-thymocyte globulinBIOLOGICAL
therapeutic allogeneic lymphocytesBIOLOGICAL
cyclophosphamideDRUG
cyclosporineDRUG
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of Hodgkin's disease or non-Hodgkin's lymphoma * Failed to achieve a complete remission with initial therapy OR * Relapsed after initial therapy * HIV-1 seropositive by Western Blot * Measurable or evaluable (e.g., pleural fluid involvement) disease * No leptomeningeal or parenchymal CNS involvement or active CNS leukemia * HLA-A, B, or DR antigen matched or 1 antigen mismatched related donor available * CD4 cell count greater than 100/mm3 (initial 12 patients) OR greater than 50/mm3 (subsequent patients)\* * HIV RNA less than 110,000 copies/mL\* NOTE: \*Unless not receiving optimal anti-retroviral therapy as defined by current clinical standards PATIENT CHARACTERISTICS: Age: * Physiologic 65 and under Performance status: * Karnofsky 70-100% Life expectancy: * Estimated disease-free survival less than 1 year Hematopoietic: * See Disease Characteristics Hepatic: * Bilirubin no greater than 2 mg/dL * Alkaline phosphatase no greater than 3 times upper limit of normal (ULN)\* * SGOT or SGPT no greater than 3 times ULN\* * Hepatitis B surface antigen negative NOTE: \*Unless receiving indinavir Renal: * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 50 mL/min Cardiovascular: * No symptomatic congestive heart failure * No angina pectoris * No uncontrolled hypertension * LVEF at least 45% by radionuclide ventriculography Pulmonary: * No severe chronic obstructive lung disease * No symptomatic restrictive lung disease * DLCO greater than 50% predicted Other: * No active uncontrolled infection * No history of cytomegalovirus retinitis or pneumonitis, even if treated * No other disease that would limit life expectancy * No symptomatic leukoencephalopathy * No neuropsychiatric abnormalities that would preclude transplantation * Human T-cell lymphotrophic virus (HTLV-1) antibody negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 1 week since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No concurrent chronic suppressive therapy

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

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma

Interventions

Antilymphocyte SerumCyclophosphamideCyclosporinePeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • David T. Scadden, MD

    Massachusetts General Hospital

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2001

First Posted

October 21, 2003

Study Start

August 1, 2001

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

February 3, 2016

Record last verified: 2016-02