Under 60, any sex, with Stem Cell Transplantation or Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Survival Rate at 100 Days Post-transplantPrimary· 100 days post-transplant
The toxicities will be monitored and scored on a daily basis following the methods of Simon R. Practical Bayesian Guideline for Phase IIB Clinical Trials. A Bayesian stopping rule will be used to stop the trial if there is a 90% chance that the true toxicity rate exceeds the target toxicity rate of 0.25.
Group
Value
95% CI
Conditioning Reg- Thiotepa, Busulfan, and Clofarabine
45
Number of Participants With Disease Free SurvivalSecondary· Up to 2 years post transplant
Kaplan-Meier product limit method to estimate the disease free survival.
Group
Value
95% CI
Conditioning Reg- Thiotepa, Busulfan, and Clofarabine
32
Overall Survival RateSecondary· Up to 3 years post transplant
Overall Survival Rate will be estimated using the Kaplan-Meier method.
Group
Value
95% CI
Conditioning Reg- Thiotepa, Busulfan, and Clofarabine
320
120 – 833
Graft vs Host Disease (GVHD)Secondary· Up to 30 days post transplant
Severity of toxicities graded according to the NCI Common Toxicity Criteria Adverse Effects (CTCAE) v3.0. Standard reporting guidelines followed for adverse events. Safety data summarized by category, severity and frequency.
Group
Value
95% CI
Conditioning Reg- Thiotepa, Busulfan, and Clofarabine
34
EngraftmentSecondary· up to 100 days post transplant
Engraftment is most commonly defined as the first of three consecutive days of achieving a sustained peripheral blood neutrophil count of \>500 × 10\^6/L .
Group
Value
95% CI
Conditioning Reg- Thiotepa, Busulfan, and Clofarabine
52
Number of Participants With Serious Adverse EventsSecondary· up to 30 days post transplant
Severity of toxicities graded according to the NCI Common Toxicity Criteria Adverse Effects (CTCAE) v3.0. Standard reporting guidelines followed for adverse events. Safety data summarized by category, severity and frequency.
Group
Value
95% CI
Conditioning Reg- Thiotepa, Busulfan, and Clofarabine
52
Relapse Rate of Participants Treated With Thiotepa, Busulfan, and ClofarabineSecondary· Up to 2 years post transplant
Relapse Rate will be estimated using the Kaplan-Meier method.
Group
Value
95% CI
Conditioning Reg- Thiotepa, Busulfan, and Clofarabine
26
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events that were related to the preparative regimen and stem cell infusion unil 30 days post transplant..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Conditioning Reg- Thiotepa, Busulfan, and Clofarabine
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.
The goal of this clinical research study is to learn if thiotepa, busulfan, and clofarabine, when given before an allogeneic (bone marrow , blood, or cord blood cells) or haploidentical (bone marrow) stem cell transplantation can help to control cancers of the bone marrow and lymph node system. The safety of this treatment will also be studied.
This is an investigational study. Thiotepa and clofarabine are FDA approved and commercially available for the treatment of leukemia. Busulfan is FDA approved and commercially available for use in stem cell transplantation. The combination of thiotepa, clofarabine, and busulfan together with a stem cell transplant is investigational.
Up to 60 participants will take part in this study. All will be enrolled at M. D. Anderson.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Trials by the same sponsor.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 7 April 2020
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/NCT00857389.