Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma

Leukemia

Leukemia, Lymphoid

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Azacitidine

Antimetabolites

Enzyme Inhibitors

Dose escalation to determine the maximum tolerated dose (MTD) of BMS-986345 in combination with Duvelisib in patients with lymphoid malignancy. Patients will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable. A total of 6 dose levels will be used.

Patients will be treated at the following dose levels:

Duvelisib BMS-986345 Dose Level 15 mg twice daily 100mg daily -1 25 mg twice daily 100mg daily 1 50 mg twice daily 100mg daily 2 75 mg twice daily 100mg daily 3 75 mg twice daily 200mg daily 4 75 mg twice daily 300mg daily 5

After the first two cycles of treatment, the dose of Duvelisib will be dropped to 25 mg twice daily irrespective of the starting dose level unless the patient is at dose level -1 then they will stay on that dose level after the initial 2 cycles

BMS-986345

Duvelisib

Hayder Saeed, MD

The purpose of the study is to find a safe dose and to evaluate the safety and tolerability of the drug BMS-986345, in combination with duvelisib.

Duvelisib in Combination With BMS-986345 in Lymphoid Malignancy

A Phase I Study of Duvelisib in Combination With BMS-986345 in Lymphoid Malignancy

Maximum Tolerated Dose (MTD) of BMS-986345 in combination with Duvelisib in patients with lymphoid malignancy. The MTD is defined as the highest dose with an observed incidence of dose limiting toxicity (DLT) in no more than one out of six patients treated at a particular dose level.

Individual best overall response at 3 and 12 months from enrollment. Patients will be categorized as either responders (complete response, partial response, stable disease) versus nonresponders (progressive disease).

Duration of response as defined starting from the first occurrence of response until disease progression or death.

Overall Survival (OS) will be measured from the initial date of treatment to date of death.

Progression Free Survival will be defined as the time from start of treatment to the time of progression or death.

Spots Global Cancer Trial Database for Duvelisib in Combination With BMS-986345 in Lymphoid Malignancy

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Study Description

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