Chronic Lymphocytic LeukemiaPhase 1NCT01832922
BR in Patients With CLL With Comorbidities and/or Renal Dysfunction
A Phase 1 study testing Bendamustine and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial summary
This is a non-randomized, open label, dose-ranging study of Bendamustine and Rituximab (BR) in patients with previously untreated or relapsed/refractory Chronic Lymphocytic Leukemia (CLL) who have multiple comorbidities with or without renal insufficiency. These agents are FDA approved for this indication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- Bendamustine and Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to 28 Nov 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or flow cytometry confirmed diagnosis of B-cell chronic lymphocytic leukemia/small lymphocytic lymphoma (B-CLL/SLL) according to NCI-WG 1996 guidelines (41). The malignant B cells must co-express CD5 with CD19 or CD20. Patients who lack CD23 expression on their leukemia cells should be examined for (and found NOT to have) either t(11;14) or cyclin D1 overexpression, to rule out mantle cell lymphoma.
- Active disease meeting at least 1 of the following IWCLL 2008 criteria for requiring treatment:
- A minimum of any one of the following constitutional symptoms:
- Unintentional weight loss >10% within the previous 6 months prior to screening.
- Extreme fatigue (unable to work or perform usual activities).
- Fevers of greater than 100.5 F for ≥2 weeks without evidence of infection.
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- Night sweats without evidence of infection.
- Evidence of progressive marrow failure as manifested by the development of, or worsening of anemia or thrombocytopenia.
- Massive (ie, >6 cm below the left costal margin), progressive or symptomatic splenomegaly.
- Massive nodes or clusters (ie, > 10 cm in longest diameter) or progressive lymphadenopathy.
- Progressive lymphocytosis with an increase of >50% over a 2-month period, or an anticipated doubling time of less than 6 months.
- Autoimmune anemia or thrombocytopenia that is poorly responsive to corticosteroids.
- Prior treatment: Patients have not had prior treatment of CLL OR Previously treated relapsed CLL patients must have received not more than 3 prior therapies for CLL. Prior bendamustine and rituximab are allowed.
- Patients must have ECOG performance status 0-3.
- Patients must have a Cumulative Illness Risk Score [CIRS]≥7 with at least one grade 3-4 category [CLL will not be considered a comorbidity]; or estimated creatinine clearance (CrCL) using the Cockcroft-Gault equation ≥15 mL/min but ≤40 ml/min (Appendix 1: CCI Criteria).
- Patients must have organ function as defined below:
- direct bilirubin ≤2 X institutional ULN (unless due to known Gilbert's syndrome or compensated hemolysis directly attributable to CLL)
- AST or ALT < 2.5 X institutional ULN
- estimated CrCL using the Cockcroft-Gault equation ≥15 mL/min.
- Absolute neutrophil count (ANC) ≥500/mm3 independent of growth factor support;
- platelets ≥30,000/mm3 independent of transfusion support with no active bleeding.
- Ability to understand and the willingness to sign a written informed consent document.
- Women of childbearing potential must have a negative serum human chorionic gonadotropin or urine pregnancy test at screening.
- All patients of reproductive potential (heterosexually active men and women) must agree to a use of a barrier method of contraception and a second method of contraception and men must agree not to donate sperm during the study and for 3 months after receiving the last dose of study treatment.
Who cannot join
- Recent therapeutic intervention including a) prior nitrosoureas or mitomycin C within 6 weeks; b) therapeutic anticancer antibodies (including rituximab) within 4 weeks; c) radio- or toxin-immunoconjugates within 10 weeks; d) all other chemotherapy, radiation therapy within 3 weeks prior to initiation of therapy.
- Inadequate recovery from adverse events related to prior therapy to grade ≤1 (excluding Grade 2 alopecia and neuropathy).
- Bendamustine-refractory (no response to a regimen containing bendamustine) or relapse following treatment with a bendamustine-containing regimen within 6 months of treatment with that regimen.
- Chronic use of corticosteroids in excess of prednisone 20 mg/day or its equivalent or chronic use of other immunosuppressive agents (azathioprine, methotrexate, tacrolimus, cyclosporine). Stem cell transplant recipients must have no evidence of active graft-versus-host disease.
- History of prior malignancy except: a) Malignancy treated with curative intent and no known active disease present for ≥ 2 years prior to initiation of therapy on current study; b) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; c) adequately treated in situ carcinomas (eg, cervical, esophageal, etc.) without evidence of disease; d) asymptomatic prostate cancer managed with "watch and wait" strategy.
- Uncontrolled immune hemolysis or thrombocytopenia (positive direct antiglobulin test in absence of hemolysis is not an exclusion).
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- Known Richter's transformation.
- Advanced renal failure (estimated CrCL < 15 mL/min) or on dialysis.
- Human Immunodeficiency Virus (HIV) or Hepatitis C antibody positivity, or active hepatitis B.
- Major surgery (requiring general anesthesia) within 30 days prior to initiation of therapy.
- Uncontrolled bacterial, viral, or fungal infection.
- Inability to adhere to the study schedule or the required follow-up.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center
Lebanon, New Hampshire, 03750
About this study
Official title: A Dose-Ranging Study of Bendamustine and Rituximab in Chronic Lymphocytic Leukemia (CLL) Patients With Comorbidities and/or Renal Dysfunction
This is a non-randomized, open label, dose-ranging study of Bendamustine and Rituximab (BR) in patients with previously untreated or relapsed/refractory Chronic Lymphocytic Leukemia (CLL) who have multiple comorbidities with or without renal insufficiency. These agents are FDA approved for this indication. However, full dose bendamustine is associated with significant hematologic toxicity and a high rate of infectious complications in "unfit" patients and patients with significantly impaired renal function. This study will attempt to optimize and define adequate and safe treatment protocols for these patients with comorbidities and/or renal dysfunction.
The study will accrue two independent patient cohorts which will follow a standard Phase I design. Patients with CLL who have significant comorbidities with or without minor renal dysfunction (CrCL>40 mL/min) will be accrued onto Cohort 1 of the study. Patients with significant renal dysfunction (CrCL<40 mL/min) will be accrued onto Cohort 2. Once the maximum tolerated dose (MTD) is determined, two expansion cohorts will be enrolled.
Read more
There will be a treatment period of up to six 28-day cycles. On C1D1 all qualifying patients will provide samples for biomarker analysis. Six patients without renal dysfunction and 6 to 9 patients with renal dysfunction will also provide samples for bendamustine PK analysis.
Accrual of both patient cohorts will occur simultaneously and will take place at two centers: Norris Cotton Cancer Center (NCCC) and Dana-Farber Cancer Institute (DFCI). Coordination of accrual to the study cohorts will be centralized at NCCC by Dr. Alexey V. Danilov.
Read the detailed description
This is a non-randomized open label dose-ranging study of Bendamustine and Rituximab (BR) in patients with previously untreated or relapsed/refractory CLL who have multiple comorbidities (Cumulative Illness Rating Scale [CIRS]≥7) with or without renal insufficiency (estimated creatinine clearance [CrCL] 15-40 mL/min, but not receiving dialysis).
The study will accrue two independent patient cohorts. Both cohorts will follow a standard 3+3 Phase I design. Once the maximum tolerated dose (MTD) is determined, two expansion cohorts will be enrolled. Dose limiting toxicities (DLT) will be assessed during the 1st cycle of treatment.
Patients with CLL who have significant comorbidities (CIRS≥7; at least one category grade 3-4), with or without minor renal dysfunction (CrCL>40 mL/min) will be accrued onto Cohort 1 of the study. At dose level 1, patients will receive bendamustine 45 mg/m2 in combination with rituximab (375 mg/m2 with cycle 1 and 500 mg/m2 with subsequent cycles). If safe, the dose of bendamustine will be escalated to 70 mg/m2 (dose level 2). By contrast, dose de-escalation to 25 mg/m2 (dose level -1) will occur in this cohort if DLT's are encountered at dose level 1. Once an MTD is determined an expansion cohort will be accrued at that dose level to allow assessment of DLT's during subsequent cycles.
Because bendamustine has not been formally studied in patients with renal failure and due to the potential for increased frequency of toxic events in such patients, patients with significant renal dysfunction (CrCL 15-40 mL/min, but not receiving dialysis) will be accrued on Cohort 2. DLT's in 0/3 (or ≤1/6) subjects with renal dysfunction at dose level 1 (as above) will permit continued accrual of such subjects onto the expansion cohort (N=10). If unacceptable toxicity is encountered, bendamustine dose will be reduced to 25 mg/m2 (dose level -1), followed by an expansion cohort if safe (10 patients). Dose escalation will not be allowed in this cohort.
Accrual of both patient cohorts will occur simultaneously (see Schema) and will take place at two centers: the ambulatory Hematology Clinics at the Norris Cotton Cancer Center (NCCC) at Dartmouth-Hitchcock Medical Center (DHMC), Lebanon, NH (Lead [Dartmouth] Principal Investigator [Lead PI] - Alexey Danilov M.D., Ph.D.), and the CLL Center at Dana-Farber Cancer Institute (DFCI), Boston, MA (DFCI Principal Investigator [DFCI PI] - Jennifer Brown M.D., Ph.D.). Coordination of accrual to the study cohorts will be centralized at the Norris Cotton Cancer Center/DHMC by Dr. Alexey V. Danilov.
- Being tested
- Bendamustine, Rituximab
- Keywords
- bendamustine, rituximab, Chronic Lymphocytic Leukemia, comorbidities, renal insufficiency
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustineDrug
Also called Treanda
RituximabDrug
Also called Rituxan
| Study group | Role | What they receive |
|---|---|---|
| Significant Comorbidiities | Experimental | Significant comorbidities as defined by Cumulative Illness Rating Score (CIRS) of ≥7. Receives: Drug: Bendamustine; Drug: Rituximab |
| Significant renal dysfunction | Active comparator | Significant renal dysfunction defined as CrCL 15-40 mL/min, but not receiving dialysis. Receives: Drug: Bendamustine; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
To evaluate the safety (MTD) of bendamustine in combination with rituximab in patients with CLL who have multiple comorbidities and/or significant renal dysfunction.
Measured: within the first 30 days of treatment
Secondary outcomes (1)
tumor response to treatment
To evaluate the efficacy of BR in patients with CLL who have multiple comorbidities and/or significant renal dysfunction.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startApr 2013
- Primary completion27 Apr 2015
- Study completion28 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Lionel.D.Lewis, MD, Dartmouth-Hitchcock Medical Center
- Investigators
- Alexey V Danilov, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832922
- Sponsor's protocol ID
- D13067
- Other IDs
- 3P30CA023108-31S4
- Status last verified
- Mar 2018
- First submitted
- 12 Apr 2013
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Ranging Study of Bendamustine and Rituximab in Chronic Lymphocytic Leukemia (CLL) Patients With Comorbidities and/or Renal Dysfunction
- ClinicalTrials.gov ID
- NCT01832922
- Acronym / sponsor ID
- D13067
- Keywords
- bendamustine, rituximab, Chronic Lymphocytic Leukemia, comorbidities, renal insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2013
- Primary completion
- 27 Apr 2015 (actual)
- Study completion
- 28 Nov 2016 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-randomized, open label, dose-ranging study of Bendamustine and Rituximab (BR) in patients with previously untreated or relapsed/refractory Chronic Lymphocytic Leukemia (CLL) who have multiple comorbidities with or without renal insufficiency. These agents are FDA approved for this indication. However, full dose bendamustine is associated with significant hematologic toxicity and a high rate of infectious complications in "unfit" patients and patients with significantly impaired renal function. This study will attempt to optimize and define adequate and safe treatment protocols for these patients with comorbidities and/or renal dysfunction.
The study will accrue two independent patient cohorts which will follow a standard Phase I design. Patients with CLL who have significant comorbidities with or without minor renal dysfunction (CrCL>40 mL/min) will be accrued onto Cohort 1 of the study. Patients with significant renal dysfunction (CrCL<40 mL/min) will be accrued onto Cohort 2. Once the maximum tolerated dose (MTD) is determined, two expansion cohorts will be enrolled.
There will be a treatment period of up to six 28-day cycles. On C1D1 all qualifying patients will provide samples for biomarker analysis. Six patients without renal dysfunction and 6 to 9 patients with renal dysfunction will also provide samples for bendamustine PK analysis.
Accrual of both patient cohorts will occur simultaneously and will take place at two centers: Norris Cotton Cancer Center (NCCC) and Dana-Farber Cancer Institute (DFCI). Coordination of accrual to the study cohorts will be centralized at NCCC by Dr. Alexey V. Danilov.
Detailed description
This is a non-randomized open label dose-ranging study of Bendamustine and Rituximab (BR) in patients with previously untreated or relapsed/refractory CLL who have multiple comorbidities (Cumulative Illness Rating Scale [CIRS]≥7) with or without renal insufficiency (estimated creatinine clearance [CrCL] 15-40 mL/min, but not receiving dialysis).
The study will accrue two independent patient cohorts. Both cohorts will follow a standard 3+3 Phase I design. Once the maximum tolerated dose (MTD) is determined, two expansion cohorts will be enrolled. Dose limiting toxicities (DLT) will be assessed during the 1st cycle of treatment.
Patients with CLL who have significant comorbidities (CIRS≥7; at least one category grade 3-4), with or without minor renal dysfunction (CrCL>40 mL/min) will be accrued onto Cohort 1 of the study. At dose level 1, patients will receive bendamustine 45 mg/m2 in combination with rituximab (375 mg/m2 with cycle 1 and 500 mg/m2 with subsequent cycles). If safe, the dose of bendamustine will be escalated to 70 mg/m2 (dose level 2). By contrast, dose de-escalation to 25 mg/m2 (dose level -1) will occur in this cohort if DLT's are encountered at dose level 1. Once an MTD is determined an expansion cohort will be accrued at that dose level to allow assessment of DLT's during subsequent cycles.
Because bendamustine has not been formally studied in patients with renal failure and due to the potential for increased frequency of toxic events in such patients, patients with significant renal dysfunction (CrCL 15-40 mL/min, but not receiving dialysis) will be accrued on Cohort 2. DLT's in 0/3 (or ≤1/6) subjects with renal dysfunction at dose level 1 (as above) will permit continued accrual of such subjects onto the expansion cohort (N=10). If unacceptable toxicity is encountered, bendamustine dose will be reduced to 25 mg/m2 (dose level -1), followed by an expansion cohort if safe (10 patients). Dose escalation will not be allowed in this cohort.
Accrual of both patient cohorts will occur simultaneously (see Schema) and will take place at two centers: the ambulatory Hematology Clinics at the Norris Cotton Cancer Center (NCCC) at Dartmouth-Hitchcock Medical Center (DHMC), Lebanon, NH (Lead [Dartmouth] Principal Investigator [Lead PI] - Alexey Danilov M.D., Ph.D.), and the CLL Center at Dana-Farber Cancer Institute (DFCI), Boston, MA (DFCI Principal Investigator [DFCI PI] - Jennifer Brown M.D., Ph.D.). Coordination of accrual to the study cohorts will be centralized at the Norris Cotton Cancer Center/DHMC by Dr. Alexey V. Danilov.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Significant Comorbidiities | Experimental | Drug: Bendamustine, Drug: RituximabSignificant comorbidities as defined by Cumulative Illness Rating Score (CIRS) of ≥7. |
| Significant renal dysfunction | Active comparator | Drug: Bendamustine, Drug: RituximabSignificant renal dysfunction defined as CrCL 15-40 mL/min, but not receiving dialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Patients must have histologically or flow cytometry confirmed diagnosis of B-cell chronic lymphocytic leukemia/small lymphocytic lymphoma (B-CLL/SLL) according to NCI-WG 1996 guidelines (41). The malignant B cells must co-express CD5 with CD19 or CD20. Patients who lack CD23 expression on their leukemia cells should be examined for (and found NOT to have) either t(11;14) or cyclin D1 overexpression, to rule out mantle cell lymphoma.
- Active disease meeting at least 1 of the following IWCLL 2008 criteria for requiring treatment:
- Prior treatment: Patients have not had prior treatment of CLL OR Previously treated relapsed CLL patients must have received not more than 3 prior therapies for CLL. Prior bendamustine and rituximab are allowed.
- Patients must have ECOG performance status 0-3.
- Patients must have a Cumulative Illness Risk Score [CIRS]≥7 with at least one grade 3-4 category [CLL will not be considered a comorbidity]; or estimated creatinine clearance (CrCL) using the Cockcroft-Gault equation ≥15 mL/min but ≤40 ml/min (Appendix 1: CCI Criteria).
Key exclusion criteria (12 listed)
- Recent therapeutic intervention including a) prior nitrosoureas or mitomycin C within 6 weeks; b) therapeutic anticancer antibodies (including rituximab) within 4 weeks; c) radio- or toxin-immunoconjugates within 10 weeks; d) all other chemotherapy, radiation therapy within 3 weeks prior to initiation of therapy.
- Inadequate recovery from adverse events related to prior therapy to grade ≤1 (excluding Grade 2 alopecia and neuropathy).
- Bendamustine-refractory (no response to a regimen containing bendamustine) or relapse following treatment with a bendamustine-containing regimen within 6 months of treatment with that regimen.
- Chronic use of corticosteroids in excess of prednisone 20 mg/day or its equivalent or chronic use of other immunosuppressive agents (azathioprine, methotrexate, tacrolimus, cyclosporine). Stem cell transplant recipients must have no evidence of active graft-versus-host disease.
- History of prior malignancy except: a) Malignancy treated with curative intent and no known active disease present for ≥ 2 years prior to initiation of therapy on current study; b) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; c) adequately treated in situ carcinomas (eg, cervical, esophageal, etc.) without evidence of disease; d) asymptomatic prostate cancer managed with "watch and wait" strategy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BendamustineAlso: Treanda | Drug | Significant Comorbidiities, Significant renal dysfunction |
| RituximabAlso: Rituxan | Drug | Significant Comorbidiities, Significant renal dysfunction |
Primary outcome
Number of participants with adverse events
Time frame: within the first 30 days of treatment
To evaluate the safety (MTD) of bendamustine in combination with rituximab in patients with CLL who have multiple comorbidities and/or significant renal dysfunction.
1 secondary outcome
tumor response to treatment
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexey V Danilov, MD principal investigator
Dartmouth-Hitchcock Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bendamustine and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: within the first 30 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2018.