Compassionate Use Study of Tenalisib (RP6530)

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.