Trial Outcomes & Findings for Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer (NCT NCT00112593)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

Within the first 100 days

Results posted on

2017-05-24

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Allogeneic Hematopoietic Stem Cell Transplantation) CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given IV or PO laboratory biomarker analysis: Correlative studies
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Allogeneic Hematopoietic Stem Cell Transplantation) n=5 Participants CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given IV or PO laboratory biomarker analysis: Correlative studies
Age, Continuous	43 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within the first 100 days

Outcome measures

Outcome measures
Measure	Treatment (Allogeneic Hematopoietic Stem Cell Transplantation) n=5 Participants CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given IV or PO laboratory biomarker analysis: Correlative studies
Death From Regimen Toxicity or Opportunistic Infection	0 Participants

PRIMARY outcome

Timeframe: Within the first 360 days

Outcome measures

Outcome measures
Measure	Treatment (Allogeneic Hematopoietic Stem Cell Transplantation) n=5 Participants CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given IV or PO laboratory biomarker analysis: Correlative studies
Death From GVHD	0 Participants

PRIMARY outcome

Timeframe: Up to day 80

Determined by a DNA-based assay that compares the profile of amplified fragment length polymorphisms (ampFLP) of the patient and donor.

Outcome measures

Outcome measures
Measure	Treatment (Allogeneic Hematopoietic Stem Cell Transplantation) n=5 Participants CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given IV or PO laboratory biomarker analysis: Correlative studies
Successful Induction of Mixed Hematopoietic Chimerism as Assessed by the Percentage of Peripheral Blood T Cells That Are of Donor Origin	5 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Kaplan-Meier estimate assessed at 1 year.

Outcome measures

Outcome measures
Measure	Treatment (Allogeneic Hematopoietic Stem Cell Transplantation) n=5 Participants CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given IV or PO laboratory biomarker analysis: Correlative studies
Overall Survival	0.40 survival probability Interval 0.14 to 1.0

SECONDARY outcome

Timeframe: Within 1 year

Count of participants with HIV progression.

Outcome measures

Outcome measures
Measure	Treatment (Allogeneic Hematopoietic Stem Cell Transplantation) n=5 Participants CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given IV or PO laboratory biomarker analysis: Correlative studies
Progression of HIV	0 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Outcome measures

Outcome measures
Measure	Treatment (Allogeneic Hematopoietic Stem Cell Transplantation) n=4 Participants CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given IV or PO laboratory biomarker analysis: Correlative studies
Reconstitution of HIV-specific Immunity	2 Participants

Adverse Events

Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ann Woolfrey, MD

Fred Hutchinson Cancer Research Center

Phone: 206-667-4453

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place