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NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders
Phase 2 trial testing anti-thymocyte globulin in Chronic Myeloproliferative Disorders in 41 participants. Completed in 19 July 2018.
| Lead sponsor | Roswell Park Cancer Institute |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 41 |
| Start date | 29 January 2002 |
| Primary completion | 19 July 2018 |
| Estimated completion | 19 July 2018 |
| Sites | 1 location across United States |
Roswell Park Cancer Institute
Adults 4 to 75, any sex, with Chronic Myeloproliferative Disorders or Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
treatment related mortality within 100 days from hematopoietic stem cell (HSC) infusion on day 0
| Group | Value | 95% CI |
|---|---|---|
| All Patients | 4 |
Best disease response measured within 100 days from hematopoietic stem cell (HSC) infusion on day 0 using disease specific response criteria defined in the protocol
| Group | Value | 95% CI |
|---|---|---|
| All Patients | 22 | |
| All Patients | 5 | |
| All Patients | 4 | |
| All Patients | 2 |
Progression free survival defined as time from HSC infusion (day 0) until progression of disease or death due to any cause. Patients are censored if alive without disease progression through 1 year after HSC infusion
| Group | Value | 95% CI |
|---|---|---|
| All Patients | 27 | 13 – 40 |
Overall survival with events defined as death due to any cause and censored patients are alive as of 1 year post HSC infusion
| Group | Value | 95% CI |
|---|---|---|
| All Patients | 44 | 29 – 59 |
overall grade II-IV acute GvHD
| Group | Value | 95% CI |
|---|---|---|
| All Patients | 16 |
Time frame: 100 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | All Patients |
|---|---|---|
| DBE/FTE | Blood and lymphatic system disorders | — |
| Reaction | System | All Patients |
|---|---|---|
| acute GVHD grade III-IV | Immune system disorders | — |
Most-reported serious reactions: DBE/FTE.
Data from ClinicalTrials.gov NCT00053989 adverse events section.
RATIONALE: Giving low doses of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy before or after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well chemotherapy followed by donor peripheral stem cell transplant works in treating patients with hematologic cancer or aplastic anemia.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00053989.
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