Clinical trial · Interventional
Phase II Trial of Pentostatin and Targeted Busulfan
Phase II Trial of Pentostatin and Targeted Busulfan as a Novel Reduced Intensity Regimen for Allogeneic Hematopoietic Stem Cell Transplantation Using Laboratory-Guided (CD4-guided) Immunosuppression.
NCT00496340CI-TRIAL-00014787Pento & tBUcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this trial is to determine whether a regimen of pentostatin and busulfan (IV) can facilitate engraftment of human leukocyte antigen (HLA) partially compatible siblings and unrelated donor transplants by using CD4+ laboratory-guided immunosuppression among 41 transplant patients meeting the inclusion criteria.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic Hematopoietic Cell Transplant | Procedure | — | UNRESOLVED |
| Busulfan | Drug | Busulfan | ALIAS |
| Pentostatin | Drug | Pentostatin | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Conditioning Followed by HCT
- description
- Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT). Pre-conditioning therapy: All participants will receive pentostatin 4 mg/m\^2 on day -28. Patients may receive additional doses on days -21 \& -14 depending on cell counts. Conditioning: 1. Patients will receive anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6. 2. Intravenous Busulfan (1st dose) at a dose of 200mg/m\^2 on day -4. 3. Patient will then receive pentostatin at a dose of 4 mg/m\^2 by intravenous infusion over 1-2 hours on days -4, -3. 4. Intravenous Busulfan (2nd dose) will be administered on day (-2) to target a total AUC of 16,000 +/- 1600. 5. Hematopoietic progenitor cells to be infused at least 36 hours after last dose of Busulfan. 6. Rituximab: Patients with CD20+ expressing malignancies will be treated with rituximab at a dose of 375 mg/m\^2 according to prescribing and institutional guidelines.
- interventionNames
- Drug: Pentostatin
- Drug: Busulfan
- Drug: Rituximab
- Procedure: Allogeneic Hematopoietic Cell Transplant
Primary outcomes (1)
- measure
- Incidence of Greater Than or Equal to 50% Donor Chimerism
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Recipients: * Age: greater than 18 years of age, or younger with parental consent. * HLA A, B, C, DRB1, DQB1, 10/10 or 9/10 allele sequence matched related donor or unrelated donor available * Histologically confirmed diagnosis by pathologic review. * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1, or Karnofsky performance status of greater than 70 * Organ function: 1. Pulmonary: diffusing capacity of lung for carbon monoxide (DLCO) \>/= 50% 2. Cardiac: left ventricular ejection fraction \>/= 50% 3. Renal: creatinine clearance (measured or calculated) equal or greater than 50 ml/min (at any time pentostatin is administered) 4. Hepatic: total bilirubin less than or equal to 2mg/dL, (Gilbert and other syndromes with increased indirect bilirubin should be allowed); serum transaminases less than two times the institutional upper limit of normal (\< 2 x ULN). Donors: * Capable of receiving Granulocyte Colony-Stimulating Factor (G-CSF) and undergo apheresis * Age \>18 * Signed informed consent form in accordance with institutional or National Donor Marrow Program (NMDP) policies Exclusion Criteria: Recipients: * Pregnant or lactating women * HIV or seropositive, confirmed by nucleic acid test (NAT) * Active central nervous system (CNS) malignancy * Active infection * Unfavorable psychosocial evaluation or history of poor compliance to prescribed medical care. * Current use of metronidazole or acetaminophen; patients must discontinue use of these agents at least 7 days prior to the start of Busulfex administration * Prior allogeneic HCT (patients who had received a prior autologous HCT will be allowed) * Lack of a capable caregiver. * Presence of any of the following comorbid conditions 1. History of recent myocardial infarction within 30 days 2. Congestive heart failure (NY class III, IV or if symptomatically uncontrolled) 3. Peripheral vascular disease (including intermittent claudication or history of bypass for arterial insufficiency) 4. Untreated thoracic or abdominal aneurysm (6 cm or more) 5. History of any cerebrovascular accident including transient ischemic attacks within 30 days 6. Dementia 7. History of recent gastrointestinal bleeding (within 30 days) 8. Connective tissue/rheumatologic disorders 9. Hemiplegia/paraplegia 10. History of solid tumor excluding skin or cervical carcinoma after curative resection. Patients with other prior solid tumor (s) who are in remission for more than 5 years will be allowed on a case-by-case basis Donors: * Pregnant or lactating women * HIV seropositive, confirmed by NAT * Human T- lymphotropic virus (HTLV) I/II seropositive * Hepatitis B or C seropositive * Donors with uncontrolled bacterial, viral, fungal or parasitic infections. * Donors with known hypersensitivity to recombinant human G-CSF or any E. coli-derived products.
References
Publications (0)
Data not yet available
No reference posted for this study.