Clinical trial · Interventional
Cloretazine (VNP40101M) With Hematopoietic Cell Transplantation for Hematologic Malignancies
Dose Escalation Trial of Cloretazine (VNP40101M) and Hematopoietic Cell Transplantation for Patients With Selected, Poor-Prognosis Hematologic Malignancies
- 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)
Primary: Define the maximal tolerated dose (MTD) of VNP40401M when given with hematopoietic cell transplantation (HCT) Secondary: * Describe the change in pharmacokinetic (PK) parameters with increasing doses of drug. * Describe and estimate the frequency of \> Grade 3 non-hematologic/non-infectious toxicities at the MTD. * Report the efficacy of the regimen. * Evaluate the rate of engraftment for the regimen.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cloretazine | Drug | — | UNRESOLVED |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cloretazine + Fludarabine
- interventionNames
- Drug: Cloretazine
- Drug: Fludarabine
Primary outcomes (1)
- measure
- To study the highest tolerable dose of VNP40101M that can be given to patients with a form of leukemia, MDS, lymphoma, or myeloma in preparation for an autologous stem cell transplant.
- timeFrame
- 2 Years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 to 65 years for autotransplant patients and age 18 to 60 years for allotransplant patients. 2. Patients with acute leukemia/MDS or lymphoid malignancies, including Hodgkin's and non-Hodgkin's lymphoma (primary refractory or refractory relapse), or multiple myeloma (beyond first remission or unresponsive to therapy), not qualifying for treatment protocols of higher priority. 3. Adequate renal function, as defined by serum creatinine \<1.5 mg/dL. 4. Adequate hepatic function, as defined by SGPT \<3 X upper limit of normal; serum bilirubin and alkaline phosphatase \<2 X upper limit of normal, or considered not attributable to liver disease in the case of alkaline phosphatase. 5. Adequate pulmonary function with FEV1, FVC and DLCO \>50% of expected corrected for hemoglobin. 6. Adequate cardiac function with left ventricular ejection fraction \>40%. No uncontrolled arrhythmias or symptomatic cardiac disease. 7. Zubrod performance status \<2 8. Patients receiving an allogeneic transplant must have a related or unrelated donor which meets departmental standards for donor selection. Exclusion Criteria: 1. Uncontrolled life-threatening infections 2. HIV positive 3. A positive Beta HCG in a woman with child bearing potential as defined as not being post-menopausal for 12 or more months or no previous surgical sterilization procedures. 4. Any CNS involvement which has not been controlled for at least 4 weeks 5. Patients must be at least 21 days from prior systemic therapy for their malignancy, or have improvement of all reversible toxicities to \</= grade 2, whichever occurs first. 6. Any patient receiving Antabuse 7. Patients should be off metronidazole (Flagyl) for at least 24 hours prior to starting VNP40401M
References
Publications (0)
Data not yet available