NCT00714103

Brief Summary

The goal of this clinical research study is to find the highest safe dose of the drug 8-chloro-adenosine that can be given in the treatment of chronic lymphocytic leukemia (CLL). Another goal is to learn how effective the drug is at treating leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_1 leukemia

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_1 leukemia

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

8.3 years

First QC Date

July 10, 2008

Last Update Submit

October 12, 2016

Conditions

LeukemiaChronic Lymphocytic Leukemia

Keywords

LeukemiaChronic Lymphocytic LeukemiaCLL8-Chloro-Adenosinepurine analoguesCancer

Outcome Measures

Primary Outcomes (1)

  • Dose-limiting Toxicity and Maximum Tolerated Dose

    During first course of treatment blood tests on Days 3 and 5; then weekly (± 3 days) evaluations and routine blood tests. Toxicity evaluation completed four weeks following initial 8-Chloro-adenosine administration.

    4 weeks

Study Arms (1)

8-Chloro-Adenosine

EXPERIMENTAL

Starting dose for first cohort of patients 45 mg/m2 intravenous over 1 hr daily for 5 days every 4 weeks (± 3 days).

Drug: 8-Chloro-Adenosine

Interventions

8-Chloro-AdenosineDRUG

45 mg/m\^2 intravenous over 1 hour daily for 5 days every 4 weeks (± 3 days).

8-Chloro-Adenosine

Eligibility Criteria

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

You may qualify if:

  • Patients must have a diagnosis of chronic lymphocytic leukemia and must be previously treated with at least one prior treatment regimen, including a purine-analogue based treatment.
  • Patients must be Rai Stage III or IV OR Rai Stage 0-II and have one or more criteria for active disease as defined by the NCI-Working Group as: a) weight loss of more than 10% in the last 6 months; b) fatigue; c) fever or night sweats without evidence of infection; d) progressive anemia or thrombocytopenia; e) progressive lymphocytosis with a lymphocyte doubling time \</= 6 months; or f) marked hypogammaglobulinemia or paraproteinemia.
  • All patients must have a Zubrod performance status of \</= 2.
  • All patients must be age \>/= 18 years.
  • Patients may not receive concurrent treatment for their CLL and must have been off treatment (chemotherapy, immunotherapy, or radiotherapy) for 4 weeks prior to treatment on this study and recovered from toxic effects of that therapy.
  • All patients must have adequate renal function indicated by serum creatinine \</=2.5x upper limits of normal (ULN) and adequate liver function indicated by ALT or AST \</= 2.5x ULN AND total bilirubin \</= 2.5x ULN.
  • All patients must have a pre-treatment platelet count of \>/= 50,000 /µl and not require transfusion to maintain this platelet count unless thrombocytopenia is due to marrow infiltrated with disease.
  • All patients or appropriate surrogate must provide informed consent.

You may not qualify if:

  • Patients with active uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia purpura.
  • Patients with active uncontrolled fungal, bacterial, or viral infection.
  • Patients who are pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaLeukemia, Lymphocytic, Chronic, B-CellNeoplasms

Interventions

8-chloroadenosine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, B-CellLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • William G. Wierda, M.D.

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 10, 2008

First Posted

July 14, 2008

Study Start

June 1, 2008

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 13, 2016

Record last verified: 2016-10

Locations

US(1)