Peripheral Stem Cell Transplantation Followed By Infusion of White Blood Cells in Treating Patients With AIDS-Related Lymphoma

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Primary Purpose

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

anti-thymocyte globulin

therapeutic allogeneic lymphocytes

cyclophosphamide

cyclosporine

peripheral blood stem cell transplantation

radiation therapy

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring AIDS-related peripheral/systemic lymphoma, HIV-associated Hodgkin lymphoma

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00024128

First Posted

September 13, 2001

Last Updated

February 1, 2016

Sponsor

AIDS Malignancy Consortium

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00024128

Brief Title

Peripheral Stem Cell Transplantation Followed By Infusion of White Blood Cells in Treating Patients With AIDS-Related Lymphoma

Official Title

Delayed Donor Leukocyte Infusions in Patients Receiving Allogeneic PBSC Following Conditioning With Non-myeloablative Regimen for AIDS-Related Lymphoma (NHL and HD)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Withdrawn prior to initiation.

Study Start Date

August 2001 (undefined)

Primary Completion Date

March 2003 (Actual)

Study Completion Date

March 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AIDS Malignancy Consortium

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

Detailed Description

OBJECTIVES: Determine the response rate of patients with AIDS-related lymphoma treated with allogeneic peripheral blood stem cell (PBSC) transplantation followed by delayed donor leukocyte infusion. Determine the complication rate of these patients treated with PBSC transplantation. Determine the immune dysfunction and recovery of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive cyclophosphamide IV over 60 minutes on days -5 to -3. Patients who have not received prior mediastinal radiotherapy receive thymic radiotherapy on day -1. Allogeneic peripheral blood stem cells are infused on day 0. Patients also receive anti-thymocyte globulin IV over 10-12 hours on days -1, 1, 3, and 5 and cyclosporine IV beginning on day -1, switching to oral when possible, and tapering until day 35. In the absence of active acute graft-versus-host disease (GVHD), and at least 2 weeks after completion of cyclosporine, patients receive an infusion of donor leukocytes on or before day 49. Patients may receive a second donor leukocyte infusion if there is evidence of persistent malignancy and no GVHD. Patients are followed through day 100, on days 120, 180, 270, and 365, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 3-4 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

AIDS-related peripheral/systemic lymphoma, HIV-associated Hodgkin lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

anti-thymocyte globulin

Intervention Type

Biological

Intervention Name(s)

therapeutic allogeneic lymphocytes

Intervention Type

Drug

Intervention Name(s)

cyclophosphamide

Intervention Type

Drug

Intervention Name(s)

cyclosporine

Intervention Type

Procedure

Intervention Name(s)

peripheral blood stem cell transplantation

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

10. Eligibility

Sex

All

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David T. Scadden, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Study Chair

Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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