Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cladribine · 2 trials · 14 indications
CRc is defined as achievement of complete remission (CR), CR with partial hematologic recovery (CRh) or CR with incomplete blood count recovery (CRi) after induction (or re-induction). The CRc rate will be computed on the safety set and presented with a point-estimate and exact binomial 95% confidence interval (CI). CRc will also be modeled with univariable logistic regressions, applied to the efficacy set, to determine if any baseline patient or disease feature is correlated with clinical response.
| Arm | Type | Description |
|---|---|---|
| Treatment (venetoclax, cladribine, cytarabine, azacitidine) | EXPERIMENTAL | See Detailed Description |
| Treatment (CLAG-M, venetoclax) | EXPERIMENTAL | Patients will receive induction with granulocyte colony-stimulating factor on days 0-5 (if peripheral white blood cell count is less than 20,000/uL), cladribine on days 1-5, cytarabine on 1-5, and mitoxantrone on days 1-3. Patients also receive venetoclax orally (PO) on days 1-14. Treatment repeats every 28-35 days for up to 2 induction cycles including mitoxantrone, and up to 4 consolidation cycles without mitoxantrone in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and/or aspiration, and blood sample collection throughout the study. |
| Name | Type | Description |
|---|---|---|
| Azacitidine | DRUG | Given IV or SC |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Marrow Aspiration | PROCEDURE | Undergo bone marrow aspiration and biopsy |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow aspiration and biopsy |
| Cladribine | DRUG | Given IV |
| Cytarabine | DRUG | Given SC |
| Echocardiography | PROCEDURE | Undergo ECHO |
| Lumbar Puncture | PROCEDURE | Undergo LP |
| Multigated Acquisition Scan | PROCEDURE | Undergo MUGA |
| Questionnaire Administration | OTHER | Ancillary studies |
| Venetoclax | DRUG | Given PO |
| Mitoxantrone | DRUG | Given IV |
| Recombinant Granulocyte Colony-Stimulating Factor | BIOLOGICAL | Given subcutaneously |
Inclusion Criteria: * Ability to comprehend the investigational nature of the study and provide informed consent (i.e., participant or legally authorized representative \[LAR\]). Written informed consent must be obtained prior to any study-specific procedures or interventions • Sign informed con...
Cladribine is being studied for the treatment of acute biphenotypic leukemia and acute monocytic leukemia, both of which are types of acute leukemia. It is also being investigated in clinical trials for acute myeloid leukemia and related high-grade myeloid neoplasms.
Cladribine is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV.
Cladribine is in clinical development. It is being evaluated in a Phase 1 trial and a Phase 2 trial, both of which are currently recruiting participants. It is an investigational drug and has not been approved by the FDA.
Cladribine is being studied in two active clinical trials. NCT04797767 is a Phase 1 trial testing venetoclax and CLAG-M in acute myeloid leukemia and high-grade myeloid neoplasms. NCT06504459 is a Phase 2 trial combining venetoclax with cladribine and cytarabine, alternating with azacitidine plus venetoclax, in newly diagnosed monocytic AML.
Cladribine is a small molecule used in oncology. Its specific molecular target is not disclosed in the available clinical trial information, but it is being studied in combination with other agents for the treatment of acute leukemias.
Cladribine is not the same as CLAG-M. CLAG-M is a chemotherapy regimen that includes cladribine, cytarabine, granulocyte colony-stimulating factor, and mitoxantrone. Cladribine is one component of the CLAG-M regimen, which is being tested in combination with venetoclax in a clinical trial.