NCT01650727

Brief Summary

The purpose of this study is to determine the maximum-tolerated dose (MTD) of dinaciclib therapy in combination with rituximab in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

July 24, 2012

Last Update Submit

February 9, 2015

Conditions

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Experiencing a Dose Limiting Toxicity (DLT)

    Cycles 2 & 3 (Days 29-84)

Study Arms (1)

Dinaciclib + Rituximab

EXPERIMENTAL

Rituximab will be administered in Cycles 1 and 3-13. Dinaciclib will be administered in Cycles 2-13.

Drug: DinaciclibBiological: Rituximab

Interventions

DinaciclibDRUG

Dinaciclib is given as a single intravenous (IV) dose on Days 1, 8, and 15 in Cycle 2 through Cycle 13 (28 day cycles) at a starting dose of 7 mg/m\^2 up to a maximum dose of 14 mg/m\^2.

Also known as: SCH 727965, MK-7965
Dinaciclib + Rituximab
RituximabBIOLOGICAL

Rituximab 375 mg/m\^2 will be administered IV on Day 1, 8, 15 and 22 in Cycle 1 (28 day cycle) and on Day 1 in Cycles 3-13 (28 day cycles).

Also known as: Rituxan®
Dinaciclib + Rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have received at least one prior therapy that includes either
  • fludarabine or equivalent nucleoside analogue or an alternative regimen
  • Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic
  • lymphoma (SLL)
  • Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2
  • Women of child-bearing potential who are sexually active, ,including both female subjects and the female sexual partners of male subjects, must agree to use a medically accepted method of contraception prior to enrollment, while receiving protocol-specified treatment, and for 12 months after stopping study treatment.
  • Women of child-bearing potential who are not currently sexually active must
  • agree to use a medically accepted method of contraception should they become
  • sexually active while participating in the study.
  • Life expectancy ≥12 weeks

You may not qualify if:

  • Symptomatic brain metastases or primary central nervous system malignancy
  • Treatment with any chemotherapy or biologic therapy within 4 weeks prior to enrollment
  • Non-hematological toxicities from prior therapy
  • Presence of any serious or uncontrolled infection defined as infection requiring hospital admission and/or parenteral antibiotics
  • Known human immunodeficiency virus (HIV) infection or a known HIV-related
  • malignancy
  • Clinically active hepatitis B or C defined as disease that requires
  • therapy
  • Women who are breast-feeding, pregnant, or intend to become pregnant
  • Prior allogeneic bone marrow transplant (auto hematopoietic stem cell
  • transplantation \[HSCT\] is allowed if fully recovered)
  • Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer from which the subject is
  • considered by his or her physician to have a 2 year survival expectation
  • Any investigational drugs within 4 weeks prior to the start of treatment
  • Concurrently receiving treatment in any other clinical study
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fabre C, Gobbi M, Ezzili C, Zoubir M, Sablin MP, Small K, Im E, Shinwari N, Zhang D, Zhou H, Le Tourneau C. Clinical study of the novel cyclin-dependent kinase inhibitor dinaciclib in combination with rituximab in relapsed/refractory chronic lymphocytic leukemia patients. Cancer Chemother Pharmacol. 2014 Nov;74(5):1057-64. doi: 10.1007/s00280-014-2583-9. Epub 2014 Sep 13.

    PMID: 25217392RESULT

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

dinaciclibRituximab

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2012

First Posted

July 26, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

February 10, 2015

Record last verified: 2015-02