A Phase 1/2 interventional study of Pentostatin and Tacrolimus in Leukemia and Lymphoma, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2015-04-28.
Sponsored by M.D. Anderson Cancer Center · Phase 1/2, Interventional, and Treatment
Primary Objective:
Secondary Objectives:
During the study, patients will have blood, urine, bone marrow, and X-ray exams done. These exams are done to monitor the results of the transplantation. Blood tests will be done daily while patients are hospitalized.
Patients in this study will receive chemotherapy and/or radiation to treat their malignancy and prevent graft rejection. This is given before the infusion of donor cells.
Patients with myeloid leukemias may receive busulfan by vein (IV) for 4 days and cyclophosphamide by vein for 2 days.
Patients with lymphoid malignancies may receive thiotepa by vein in one dose, cyclophosphamide by vein for 2 days, and irradiation for 4 days.
Other chemotherapy treatments may be used before donor cell infusion.
IV injections will be given through a previously inserted catheter that extends into the vena cava (a large chest vein).
Patients will be randomly picked (as in the toss of a coin) to receive one of five different treatments. This is done to learn the benefit of pentostatin treatment and the appropriate dose. Four of the treatments will use different dose schedules of pentostatin. The fifth treatment group will receive no pentostatin at all. All patients receive tacrolimus and methotrexate.
Pentostatin will be given by vein in 4 doses during the first month after transplant. Tacrolimus (FK506) will be given by vein or mouth for 6 months. Methotrexate will be given by vein for 3 doses in the first week after transplant.
Patients will receive blood and platelet transfusions after the transplant. The number of transfusions will depend on how quickly the blood cell counts return to a normal range.
Patients will remain in the hospital for about 4-6 weeks and in the Houston area for 100 days after the transplant.
This is an investigational study. All of the study drugs are commercially available. Pentostatin will not be used for GVHD prevention outside of this study. A total of 150 patients will take part in this study.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 150 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group 1: No Pentostatin
Drug: Pentostatin · Drug: Tacrolimus · Drug: Methotrexate
Group 2: Pentostatin 0.5 mg/m\^2
Drug: Pentostatin · Drug: Tacrolimus · Drug: Methotrexate
Group 3: Pentostatin 1 mg/m\^2
Drug: Pentostatin · Drug: Tacrolimus · Drug: Methotrexate
Group 4: Pentostatin 1.5 mg/m\^2
Drug: Pentostatin · Drug: Tacrolimus · Drug: Methotrexate
Group 5: Pentostatin 2 mg/m\^2
Drug: Pentostatin · Drug: Tacrolimus · Drug: Methotrexate
Given intravenously on days +8, +15, +22 and +30 post transplant: Group 2 - Pentostatin 0.5 mg/m\^2 Group 3 - Pentostatin 1 mg/m\^2 Group 4 - Pentostatin 1.5 mg/m\^2 Group 5 - Pentostatin 2 mg/m\^2
Also known as: Nipent, Deoxycoformycin, DCF
Given intravenously from day -2, and will be switched to oral dosing when tolerated.
Also known as: Prograf
Given intravenously on days +1, +3, and +6 at the dose of 5 mg/m2.
Number of Patients Without GVHD at 100 Days
The primary efficacy endpoint of escalating doses Pentostatin with Tacrolimus + Methotrexate is success, defined to be that the patient is alive, engrafted, and without acute graft-versus-host disease (GVHD) at 100 days.
Time frame: 100 days
Recruitment Period: September 15, 2000 to July 26, 2007; All recruitment done at UT MD Anderson Cancer Center
| Milestone | No Pentostatin | Pentostatin 0.5 | Pentostatin 1 | Pentostatin 1.5 | Pentostatin 2 |
|---|---|---|---|---|---|
| Started | 37 | 10 | 29 | 63 | 11 |
| Completed | 37 | 10 | 29 | 61 | 10 |
| Not completed | 0 | 0 | 0 | 2 | 1 |
| Withdrew: Physician decision | 0 | 0 | 0 | 2 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 1 |
The primary efficacy endpoint of escalating doses Pentostatin with Tacrolimus + Methotrexate is success, defined to be that the patient is alive, engrafted, and without acute graft-versus-host disease (GVHD) at 100 days.
| participants | Pentostatin |
|---|---|
| Number of Patients Without GVHD at 100 Days | 100 |
Collected over 7 Years. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Pentostatin | — | 0/27 (0%) | 28/37 (75.7%) |
| Pentostatin 0.5 | — | 0/10 (0%) | 9/10 (90%) |
| Pentostatin 1 | — | 0/29 (0%) | 17/29 (58.6%) |
| Pentostatin 1.5 | — | 0/61 (0%) | 40/61 (65.6%) |
| Pentostatin 2 | — | 0/10 (0%) | 7/10 (70%) |
| Event | No Pentostatin | Pentostatin 0.5 | Pentostatin 1 | Pentostatin 1.5 | Pentostatin 2 |
|---|---|---|---|---|---|
| TTP/HUSRenal and urinary disorders | 0/37 | 0/10 | 0/29 | 5/61 | 7/10 |
| bacterialInfections and infestations | 24/37 | 6/10 | 17/29 | 38/61 | 7/10 |
| Increased CreatinineRenal and urinary disorders | 11/37 | 6/10 | 4/29 | 21/61 | 4/10 |
| CMVInfections and infestations | 21/37 | 3/10 | 12/29 | 27/61 | 5/10 |
| viralInfections and infestations | 5/37 | 2/10 | 7/29 | 24/61 | 1/10 |
| fungalInfections and infestations | 5/37 | 2/10 | 7/29 | 24/61 | 1/10 |
| parasiteInfections and infestations | 0/37 | 0/10 | 1/29 | 3/61 | 0/10 |
| Age, Categorical(Participants) | No Pentostatin | Pentostatin 0.5 | Pentostatin 1 | Pentostatin 1.5 | Pentostatin 2 | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 36 | 10 | 28 | 61 | 11 | 146 |
| >=65 years | 1 | 0 | 1 | 2 | 0 | 4 |
| Age, Continuous(years) | No Pentostatin | Pentostatin 0.5 | Pentostatin 1 | Pentostatin 1.5 | Pentostatin 2 | Total |
|---|---|---|---|---|---|---|
| Mean | 50 ± 19 | 42 ± 23 | 47 ± 20 | 50 ± 22 | 45 ± 32 | 46.8 ± 23.2 |
| Sex: Female, Male(Participants) | No Pentostatin | Pentostatin 0.5 | Pentostatin 1 | Pentostatin 1.5 | Pentostatin 2 | Total |
|---|---|---|---|---|---|---|
| Female | 15 | 3 | 11 | 30 | 7 | 66 |
| Male | 22 | 7 | 18 | 33 | 4 | 84 |
| Region of Enrollment(participants) | No Pentostatin | Pentostatin 0.5 | Pentostatin 1 | Pentostatin 1.5 | Pentostatin 2 | Total |
|---|---|---|---|---|---|---|
| United States | 37 | 10 | 29 | 63 | 11 | 150 |
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center