Trial Outcomes & Findings for Phase I/II Trial of R-CHOP + Azacytidine in Diffuse Large B Cell Lymphoma (NCT NCT01004991)

Results Overview

Complete Response

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

14 participants

Primary outcome timeframe

13 months

Results posted on

2017-04-10

Participant milestones
Measure	All Patients subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP rituximab: 375 mg/m2 on Day 8 of each of 6 cycles cyclophosphamide: 750 mg/m2 on Day 8 of each of 6 cycles vincristine: 1.4 mg/m2 on Day 8 of each of 6 cycles doxorubicin: 50 mg/m2 on Day 8 of each of 6 cycles prednisone: 100 mg PO days 8-12 of each of 6 cycles azacytidine: Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Phase I/II Trial of R-CHOP + Azacytidine in Diffuse Large B Cell Lymphoma

Baseline characteristics by cohort
Measure	All Patients n=12 Participants subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP rituximab: 375 mg/m2 on Day 8 of each of 6 cycles cyclophosphamide: 750 mg/m2 on Day 8 of each of 6 cycles vincristine: 1.4 mg/m2 on Day 8 of each of 6 cycles doxorubicin: 50 mg/m2 on Day 8 of each of 6 cycles prednisone: 100 mg PO days 8-12 of each of 6 cycles azacytidine: Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

Timeframe: 13 months

Complete Response

Outcome measures
Measure	All Patients n=12 Participants subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP rituximab: 375 mg/m2 on Day 8 of each of 6 cycles cyclophosphamide: 750 mg/m2 on Day 8 of each of 6 cycles vincristine: 1.4 mg/m2 on Day 8 of each of 6 cycles doxorubicin: 50 mg/m2 on Day 8 of each of 6 cycles prednisone: 100 mg PO days 8-12 of each of 6 cycles azacytidine: Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5
Complete Response	11 Participants

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	All Patients n=12 participants at risk all study patients
Blood and lymphatic system disorders Neutropenia	100.0% 12/12
Blood and lymphatic system disorders Neutropenic Fever	33.3% 4/12
Blood and lymphatic system disorders thrombocytopenia	8.3% 1/12

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