Clinical trial · Interventional
Compassionate Use Study of Tenalisib (RP6530)
An Open Label, Compassionate Use Study of Tenalisib (RP6530) in Patients Currently Receiving Treatment on Tenalisib Trials in Hematological 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)
Tenalisib has been evaluated as an investigational new drug in number of early clinical studies in patients with relapsed/refractory hematological malignancies and demonstrated acceptable safety and promising efficacy in these patients. Since these advanced relapsed/refractory patients have limited therapeutic options, it is reasonable to continue Tenalisib in responding patients post completion of their participation in previous clinical studies.
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 |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tenalisib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tenalisib
- description
- Participants receive Tenalisib (RP6530) BID Orally
- interventionNames
- Drug: Tenalisib
Primary outcomes (2)
- measure
- Treatment-related Adverse Events
- timeFrame
- 2 years
- description
- To evaluate the safety and tolerability of Tenalisib as single agent. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- measure
- Time to Disease Progression
- timeFrame
- 2 years
- description
- Number of patients with a time to progression. The time to progression is calculated from the day of enrollment in the study to disease progression or death due to any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must be currently receiving treatment with Tenalisib on a previously approved protocol. 2. Patients must have had at least one efficacy evaluation in previous study and should have achieved either SD, PR or CR. 3. Patients must have completed at least 6 cycles of Tenalisib in previous study 4. Ability to swallow and retain oral medication. 5. Female patients of child-bearing potential must consent to use two medically acceptable methods of contraception. 6. Male patients must be willing to use adequate contraceptive measures 7. Willingness and ability to comply with trial and follow-up procedures. 8. Willingness to provide new written informed consent. Exclusion Criteria: 1. Patient has been discontinued from their previous Tenalisib study 4 weeks prior to entering the compassionate use trial. 2. Patient progressed while receiving Tenalisib therapy in his/her previous study. 3. Pregnant or lactating woman. 4. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol. 5. Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.
References
Publications (0)
Data not yet available