Compassionate Use Study of Tenalisib (RP6530)

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label, Compassionate Use Study of Tenalisib (RP6530) in Patients Currently Receiving Treatment on Tenalisib Trials in Hematological Malignancies

Conditions
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Hematological Malignancies

Intervention / Treatment
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* Drug: Tenalisib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be currently receiving treatment with Tenalisib on a previously approved protocol. Patients must have had at least one efficacy evaluation in previous study and should have achieved either SD, PR or CR. Patients must have completed at least 6 cycles of Tenalisib in previous study Ability to swallow and retain oral medication. Female patients of child-bearing potential must consent to use two medically acceptable methods of contraception. Male patients must be willing to use adequate contraceptive measures Willingness and ability to comply with trial and follow-up procedures. Willingness to provide new written informed consent. Exclusion Criteria: Patient has been discontinued from their previous Tenalisib study 4 weeks prior to entering the compassionate use trial. Patient progressed while receiving Tenalisib therapy in his/her previous study. Pregnant or lactating woman. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol. Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tenalisib<br>Participants receive Tenalisib (RP6530) BID Orally | Drug: Tenalisib<br>* BID Orally<br>* Other names: RP6530;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | To evaluate the safety and tolerability of Tenalisib as single agent | 2 years | 
| Time to disease progression |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematological Malignancies, Tenalisib, RP6530, Compassionate Use