A Phase 2 interventional study of Obinutuzumab and Chlorambucil in Chronic Lymphocytic Leukemia, sponsored by Genentech, Inc.. Completed at 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-17.
Sponsored by Genentech, Inc. · Phase 2, Interventional, and Treatment
This is a multicenter, open-label, single-arm, expanded access treatment study designed to provide obinutuzumab to patients with previously untreated Chronic Lymphocytic Leukemia (CLL) in combination with chlorambucil and to evaluate the safety and efficacy of obinutuzumab administered in combination with chlorambucil. This study will enroll patients with previously untreated CD20-positive CLL requiring treatment according to the IWCLL guidelines (Hallek et al 2008), as assessed by the investigator.
5,441 studies on the registry are indexed under Leukemia; 637 are open to participants now.
This study's enrollment of 20 is below the median of 38 across 4,248 interventional studies indexed under Leukemia.
Browse Leukemia studies →Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.
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Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
Drug: Obinutuzumab · Drug: Chlorambucil
Also known as: RO 5072759, GA101
Number of Participants Who Received Obinutuzumab and Chlorambucil in the Study
Number of participants who received obinutuzumab and chlorambucil in the study are presented in the below table.
Time frame: Cycles 1 to 6 (28-day cycles)
Number of Participants With Adverse Events (AEs), AEs of Grade 3 and Above Severity, AEs of Special Interest (AESI), AEs Leading to Obinutuzumab Discontinuation or Dose Delays, Serious Adverse Events (SAEs), and Death
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 was used for grading the AEs. According to NCI CTCAE, Grade 3 = severe or medically significant but not immediately life threatening; Grade 4 = life-threatening consequences, urgent intervention indicated, and Grade 5 = death. AESIs included all tumor lysis syndrome, serious infections, serious infusion-related reactions (IRR), and hepatitis B reactivation. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Time frame: Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
Number of Participants With Objective Response
Objective response is defined as either complete response \[CR\], complete response with incomplete recovery \[CRi\], or partial response \[PR\] as determined by the treating physician's standard practice at the end of treatment or premature discontinuation from study per the International Workshop on Chronic Lymphocytic Leukemia Criteria (iwCLL criteria). Patients who have not achieved a CR or a PR, and who have not exhibited progressive disease, will be considered to have stable disease (which is equivalent to a nonresponse).
Time frame: Up to end of treatment or premature discontinuation from study (up to 7 months from Day 1)
A total of 20 participants were enrolled at 7 study sites in the United States (U.S) between 21 August 2013 and 22 January 2014.
| Milestone | Obinutuzumab + Chlorambucil |
|---|---|
| Started | 20 |
| Completed | 0 |
| Not completed | 20 |
| Withdrew: Adverse event | 2 |
| Withdrew: Commercial availability of study drug | 17 |
| Withdrew: Neutropenia | 1 |
Number of participants who received obinutuzumab and chlorambucil in the study are presented in the below table.
| participants | Obinutuzumab | Chlorambucil |
|---|---|---|
| Number of Participants Who Received Obinutuzumab and Chlorambucil in the Study | 19 | 19 |
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 was used for grading the AEs. According to NCI CTCAE, Grade 3 = severe or medically significant but not immediately life threatening; Grade 4 = life-threatening consequences, urgent intervention indicated, and Grade 5 = death. AESIs included all tumor lysis syndrome, serious infections, serious infusion-related reactions (IRR), and hepatitis B reactivation. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
| participants | Obinutuzumab + Chlorambucil |
|---|---|
| Any AEs | 19 |
| Any AEs of Grade 3 and more severity | 10 |
| AEs leading to obinutuzumab discont. or delay | 8 |
| AESI | 1 |
| Any SAEs | 2 |
| Death | 0 |
Objective response is defined as either complete response \[CR\], complete response with incomplete recovery \[CRi\], or partial response \[PR\] as determined by the treating physician's standard practice at the end of treatment or premature discontinuation from study per the International Workshop on Chronic Lymphocytic Leukemia Criteria (iwCLL criteria). Patients who have not achieved a CR or a PR, and who have not exhibited progressive disease, will be considered to have stable disease (which is equivalent to a nonresponse).
| participants | Obinutuzumab + Chlorambucil |
|---|---|
| Number of Participants With Objective Response | 4 |
Collected over Up to 28 days after the last dose of study drug (up to 7 months from Day 1). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Obinutuzumab + Chlorambucil | — | 2/19 (10.5%) | 18/19 (94.7%) |
| Event | Obinutuzumab + Chlorambucil |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 1/19 |
| Esophageal hemorrhageGastrointestinal disorders | 1/19 |
| Eesophageal ulcersGastrointestinal disorders | 1/19 |
| Infusion Related ReactionInjury, poisoning and procedural complications | 1/19 |
| Event | Obinutuzumab + Chlorambucil |
|---|---|
| Infusion related reactionInjury, poisoning and procedural complications | 12/19 |
| Lymphocyte count decreasedInvestigations | 7/19 |
| NeutropeniaBlood and lymphatic system disorders | 6/19 |
| InsomniaPsychiatric disorders | 6/19 |
| LeukopeniaBlood and lymphatic system disorders | 5/19 |
| ThrombocytopeniaBlood and lymphatic system disorders | 5/19 |
| NauseaGastrointestinal disorders | 5/19 |
| White blood cell count decreasedInvestigations | 5/19 |
| DiarrhoeaGastrointestinal disorders | 4/19 |
| HyponatraemiaMetabolism and nutrition disorders | 4/19 |
Safety population which included all enrolled patients who received at least one dose of study drug (obinutuzumab).
| Age, Continuous(years) | Obinutuzumab + Chlorambucil |
|---|---|
| Mean | 67.5 ± 10.33 |
| Sex: Female, Male(Participants) | Obinutuzumab + Chlorambucil |
|---|---|
| Female | 6 |
| Male | 13 |
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Genentech, Inc.