Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cladribine · 1 trial · 1 indication
PD occurred if any of the following events was observed: appearance of any new lesion, such as enlarged lymph nodes (greater than \[\>\]1.5 centimeters \[cm\]), splenomegaly, hepatomegaly, or other organ infiltrates; an increase of greater than or equal to (\>/=) 50 percent (%) in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by \>/=50%; an increase in the number of blood lymphocytes by \>/=50% with B-lymphocytes \>/=5000 per microliter (/mcL); transformation to a more aggressive histology; occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL.
PFS was defined as the time from date of randomization to date of PD, relapse, or death due to any cause. Participants alive with no evidence of PD or relapse were censored at date of last clinical examination. PD occurred if any of the following events was observed: appearance of any new lesion, such as enlarged lymph nodes (\>1.5 cm), splenomegaly, hepatomegaly, or other organ infiltrates; an increase of \>/=50% in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by \>/=50%; an increase in the number of blood lymphocytes by \>/=50% with B-lymphocytes \>/=5000/mcL; transformation to a more aggressive histology; occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL.
| Arm | Type | Description |
|---|---|---|
| Induction: Rituximab, Cladribine, Cyclophosphamide | EXPERIMENTAL | Participants will receive rituximab at a dose of 375 milligrams per meter squared (mg/m\^2) as intravenous (IV) infusion on Day 1, cladribine at a dose of 0.12 milligrams per kilogram per day (mg/kg/day) as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m\^2/day as IV infusion over 15-30 minutes on Days 2-4 in Cycle 1. Then, rituximab at a dose of 500 mg/m\^2 as IV infusion on Day 1, cladribine at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4, and cyclophosphamide at a dose of 250 mg/m\^2/day as IV infusion over 15-30 minutes on Days 2-4 will be administered in Cycles 2-6. Each cycle will be of 28 days in duration. |
| Maintenance Arm: Rituximab | EXPERIMENTAL | Participants with PR or CR after induction phase who will be randomized to maintenance arm will receive rituximab treatment for 8 cycles. Twelve weeks after the last induction cycle, participants will receive rituximab at a dose of 375 mg/m\^2 as IV infusion on Day 1 of each 12-week cycle until disease progression (up to approximately 96 weeks). |
| Observation Arm: No Intervention | NO_INTERVENTION | Participants with PR or CR after induction phase who will be randomized to observation arm will not receive any intervention. Participants will be assessed every 4-weeks for the first 12 weeks and every 12-weeks afterwards up to 96 weeks. |
| Name | Type | Description |
|---|---|---|
| Cladribine | DRUG | Cladribine will be adminiatered at a dose of 0.12 mg/kg/day as IV infusion on Days 2-4 of each 28-day cycle during induction phase. |
| Cyclophosphamide | DRUG | Cyclophosphamide will be administred at a dose of 250 mg/m\^2/day as IV infusion over 15-30 minutes on Days 2-4 of each 28-day cycle during induction phase. |
| Rituximab | DRUG | Rituximab will be administered at a dose of 375 mg/m\^2 as IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 as IV infusion on Day 1 of Cycles 2-6 during induction phase. Rituximab will be administered at a dose of 375 mg/m\^2 as IV infusion on Day 1 of each 12-week cycle during maintenance phase. |
Inclusion Criteria: * Immunologically confirmed diagnosis of B-cell CLL * Rai stage I-IV disease with evidence of progression * No previous chemotherapy, radiotherapy, or immunotherapy for B-cell CLL * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: * Ac...
Cladribine is a small molecule being studied for the treatment of chronic lymphocytic leukemia (CLL). It is currently in Phase 3 clinical development. The drug is being evaluated as a maintenance treatment for patients with progressive B-cell CLL, with the goal of assessing its effect compared to no treatment.
Cladribine is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is conducting clinical trials to evaluate the drug's use in chronic lymphocytic leukemia. The company is responsible for the ongoing Phase 3 development program for this investigational therapy.
Cladribine is in Phase 3 clinical development for chronic lymphocytic leukemia. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform whether the drug progresses toward regulatory submission.
Cladribine is being studied in a completed Phase 3 clinical trial with the identifier NCT00718549. This trial assessed the effect of maintenance treatment with Cladribine versus no treatment in participants with progressive B-cell chronic lymphocytic leukemia. The study enrolled 128 participants and was conducted in Belarus and Poland.
No, Cladribine is not the same as rituximab. Cladribine is a small molecule being studied as a maintenance treatment for chronic lymphocytic leukemia. Rituximab is a separate drug that was used as a comparator in the clinical trial, but the two are distinct therapies with different mechanisms and origins.