BMT CTN 0803
BMT CTN 0803 showed that people living with HIV whose lymphoma had come back can have the same high-dose chemotherapy and stem cell transplant as anyone else, with 87 percent alive at one year and outcomes no different from matched HIV-negative patients, so HIV alone should not bar transplant.
Overview
BMT CTN 0803/AMC 071 was a single-arm phase 2 trial of the Blood and Marrow Transplant Clinical Trials Network and the AIDS Malignancy Consortium in 43 HIV-infected patients with chemotherapy-sensitive relapsed or persistent aggressive B-cell or Hodgkin lymphoma; 40 underwent autologous transplant after BEAM conditioning with protocol-defined management of antiretroviral therapy around transplant. The primary endpoint was one-year overall survival.
At a median follow-up of 24.8 months, one- and two-year overall survival were 87.3 and 82 percent, two-year progression-free survival 79.8 percent and one-year transplant-related mortality 5.2 percent; engraftment was prompt and outcomes did not differ from 151 matched HIV-negative registry controls. The corpus's HIV-associated lymphoma page cites BMT CTN 0803 for autologous transplant being feasible with controlled HIV.
- 87.3 out of 100 people alive at 1 year with BEAM and autologous transplant in HIV-infected patients.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 82 out of 100 people alive at 2 years with BEAM and autologous transplant in HIV-infected patients.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 79.8 out of 100 people alive without the cancer growing at 2 years with BEAM and autologous transplant in HIV-infected patients.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 5.2 out of 100 people alive at 1 year with BEAM and autologous transplant in HIV-infected patients.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- These results apply to the people the trial enrolled: HIV-infected patients over 15 with chemotherapy-sensitive relapsed or persistent aggressive B-cell lymphoma or Hodgkin lymphoma and treatable HIV: high-dose carmustine, etoposide, cytarabine and melphalan (BEAM) with autologous stem cell transplant and consistent peri-transplant antiretroviral management. People in a different situation may not see the same effect.
- Only 43 people took part, so the numbers are less certain than in a large trial.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
43 enrolled.
95% CI 72.1 to 94.5; 43 enrolled, 40 transplanted
Source95% CI 65.9 to 91
Source95% CI 63.7 to 89.4
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival at 1 yearprimary | BEAM and autologous transplant in HIV-infected patients | 40 | 87.3% | - | - | link |
| Overall survival at 2 years | BEAM and autologous transplant in HIV-infected patients | 40 | 82% | - | - | link |
| Progression-free survival at 2 years | BEAM and autologous transplant in HIV-infected patients | 40 | 79.8% | - | - | link |
| Transplant-related mortality at 1 year | BEAM and autologous transplant in HIV-infected patients | 40 | 5.2% | - | - | link |
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