NCT00810680

Brief Summary

The purpose of this study is to determine whether Valproic acid, as a single agent is effective in the treatment of Chronic Lymphocytic Leukemia which has relapsed or is refractory to therapy with standard drugs.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

December 18, 2008

Status Verified

December 1, 2008

Enrollment Period

6 months

First QC Date

October 21, 2008

Last Update Submit

December 17, 2008

Conditions

Chronic Lymphocytic Leukemia

Keywords

chronic lymphocytic leukemiarelapsedrefractoryvalproic acidvalproate

Outcome Measures

Primary Outcomes (1)

  • Best clinical response as defined by NCIWG criteria for CLL

    3 months

Secondary Outcomes (2)

  • Hematological toxicity (graded according to NCIWG criteria for CLL)

    3 months

  • Non- hematological toxicity (graded according to NCI common toxicity criteria)

    3 months

Study Arms (1)

Valproic acid

EXPERIMENTAL
Drug: Valproic acid

Interventions

Valproic acidDRUG

Tab. Valproic acid will be started at a dose of 10 mg per kg per day in two or three divided doses. If well tolerated the dose will be increased to a maximum of 20 mg per kg per day and continued for a period of 3 months. The drug will be continued for another 3 months for a maximum of 6 months in responding patients. The drug will be stopped in all those who develop intolerable side effects or develop disease progression during therapy.

Also known as: Valproate, Sodium Valproate, Depakote
Valproic acid

Eligibility Criteria

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

You may qualify if:

  • Active CLL (as defined by the National Cancer Institute Working Group)
  • Patients must have received at least one prior therapy for CLL and have been treated with a nucleoside analogue.
  • Age 18 years or older.
  • Good general condition as defined by an Eastern cooperative oncology group- performance status (ECOG-PS) \</=2.
  • Absolute neutrophil count\>1500/cmm and platelet count \>30,000/cmm unless the low counts are due to the disease.
  • Adequate liver function (bilirubin\<2 mg/dL,ASTorALT \<3Xthe upper limit of normal) and renal function (serum creatinine\<2 mg/dL or creatinine clearance\>30 mL/min) unless abnormalities are as a result of disease involvement.
  • Full recovery from previous treatments.

You may not qualify if:

  • Any therapy for CLL within 4 weeks before initiating treatment on this study.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute Rotary Cancer Hospital, All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

Related Publications (1)

  • Bokelmann I, Mahlknecht U. Valproic acid sensitizes chronic lymphocytic leukemia cells to apoptosis and restores the balance between pro- and antiapoptotic proteins. Mol Med. 2008 Jan-Feb;14(1-2):20-7. doi: 10.2119/2007-00084.Bokelmann.

    PMID: 17973028BACKGROUND

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellRecurrence

Interventions

Valproic Acid

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)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Vinod Raina, MD, FRCP

    Institute Rotary Cancer Hospital, AIIMS, New delhi, India

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vinod Raina, MD, FRCP

CONTACT

91-11-2659 3679vinodraina@hotmail.com

Prasanth Ganesan, MD

CONTACT

91-99681-47800pg1980@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 21, 2008

First Posted

December 18, 2008

Study Start

September 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

December 18, 2008

Record last verified: 2008-12

Locations

IN(1)