WithdrawnPhase 2

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

Stopped: Withdrawn prior to initiation.

0Started 2001-08

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 restrictiv…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00024128

SponsorAIDS Malignancy Consortium

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2003-03

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