Cladribine

Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, Multiple Sclerosis + 3 more

Treatment

2 FDA approvals

20 Active Studies for Cladribine

What is Cladribine

Cladribine

The Generic name of this drug

Treatment Summary

An antineoplastic agent is a type of medication used to treat lymphoproliferative diseases, such as hairy-cell leukemia.

Leustatin

is the brand name

image of different drug pills on a surface

Cladribine Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Leustatin

Cladribine

1993

13

Approved as Treatment by the FDA

Cladribine, also called Leustatin, is approved by the FDA for 2 uses which include Hairy Cell Leukemia (HCL) and Hairy Cell Leukemia .

Hairy Cell Leukemia (HCL)

Hairy Cell Leukemia

Effectiveness

How Cladribine Affects Patients

Cladribine is a chemical used to treat cancer. It is similar to another chemical, deoxyadenosine, but with an extra chlorine atom that makes it more powerful. Cladribine has a longer lasting effect than deoxyadenosine on resting and growing cells, and is part of a group of drugs called anti-metabolites. These drugs prevent cells from making and repairing their DNA, which stops cancer cells from growing and spreading.

How Cladribine works in the body

Cladribine works differently than other drugs. It is changed by an enzyme into a form that gets absorbed into DNA and stops it from copying. This causes cells, like lymphocytes, to break down and die. Cladribine affects resting and active cells, and it also stops DNA repair. It also binds to a protein called PNP, but we don't know how this affects its action.

When to interrupt dosage

The endorsed measure of Cladribine is subject to the diagnosed condition, for example Non-Hodgkin's Lymphoma, Hairy Cell Leukemia and Chronic Lymphocytic Leukemia. The quantity of dosage can be found in the table below, contingent upon the technique of delivery (e.g. Solution - Intravenous or Injection).

Condition

Dosage

Administration

Chronic Lymphocytic Leukemia

, 1.0 mg/mL, 10.0 mg, 2.0 mg/mL

Intravenous, Injection, , Injection - Intravenous, Solution, Solution - Intravenous, Tablet, Oral, Tablet - Oral, Injection, solution - Intravenous, Injection, solution, Injection, solution - Subcutaneous, Subcutaneous

Multiple Sclerosis

, 1.0 mg/mL, 10.0 mg, 2.0 mg/mL

Intravenous, Injection, , Injection - Intravenous, Solution, Solution - Intravenous, Tablet, Oral, Tablet - Oral, Injection, solution - Intravenous, Injection, solution, Injection, solution - Subcutaneous, Subcutaneous

Diagnostic Imaging

, 1.0 mg/mL, 10.0 mg, 2.0 mg/mL

Intravenous, Injection, , Injection - Intravenous, Solution, Solution - Intravenous, Tablet, Oral, Tablet - Oral, Injection, solution - Intravenous, Injection, solution, Injection, solution - Subcutaneous, Subcutaneous

Non-Hodgkin's Lymphoma

, 1.0 mg/mL, 10.0 mg, 2.0 mg/mL

Intravenous, Injection, , Injection - Intravenous, Solution, Solution - Intravenous, Tablet, Oral, Tablet - Oral, Injection, solution - Intravenous, Injection, solution, Injection, solution - Subcutaneous, Subcutaneous

Hairy Cell Leukemia

, 1.0 mg/mL, 10.0 mg, 2.0 mg/mL

Intravenous, Injection, , Injection - Intravenous, Solution, Solution - Intravenous, Tablet, Oral, Tablet - Oral, Injection, solution - Intravenous, Injection, solution, Injection, solution - Subcutaneous, Subcutaneous

CTAGE1 protein, human

, 1.0 mg/mL, 10.0 mg, 2.0 mg/mL

Intravenous, Injection, , Injection - Intravenous, Solution, Solution - Intravenous, Tablet, Oral, Tablet - Oral, Injection, solution - Intravenous, Injection, solution, Injection, solution - Subcutaneous, Subcutaneous

Warnings

There are 20 known major drug interactions with Cladribine.

Common Cladribine Drug Interactions

Drug Name

Risk Level

Description

2-Methoxyethanol

Major

The risk or severity of adverse effects can be increased when Cladribine is combined with 2-Methoxyethanol.

9-(N-methyl-L-isoleucine)-cyclosporin A

Major

The risk or severity of adverse effects can be increased when Cladribine is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.

Abatacept

Major

The risk or severity of adverse effects can be increased when Cladribine is combined with Abatacept.

Abetimus

Major

The risk or severity of adverse effects can be increased when Cladribine is combined with Abetimus.

Acteoside

Major

The risk or severity of adverse effects can be increased when Cladribine is combined with Acteoside.

Cladribine Toxicity & Overdose Risk

Overdosing on Cisatracurium may lead to irreversible nerve damage, kidney damage, and decreased numbers of white blood cells, red blood cells, and platelets.

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Cladribine Novel Uses: Which Conditions Have a Clinical Trial Featuring Cladribine?

At present, there are 380 ongoing trials investigating the potential of Cladribine to target CTAGE1 protein, human, Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma.

Condition

Clinical Trials

Trial Phases

Chronic Lymphocytic Leukemia

142 Actively Recruiting

Phase 1, Phase 2, Not Applicable, Phase 3, Early Phase 1, Phase 4

CTAGE1 protein, human

13 Actively Recruiting

Phase 1, Not Applicable, Phase 2, Early Phase 1, Phase 3

Hairy Cell Leukemia

15 Actively Recruiting

Phase 2, Phase 1

Non-Hodgkin's Lymphoma

115 Actively Recruiting

Phase 1, Phase 2, Not Applicable, Phase 3, Early Phase 1, Phase 4

Diagnostic Imaging

0 Actively Recruiting

Multiple Sclerosis

12 Actively Recruiting

Phase 3, Phase 4, Phase 2

Cladribine Reviews: What are patients saying about Cladribine?

5

Patient Review

11/14/2007

Cladribine for Type of Leukemia - Hairy Cell Leukemia

I found that I was getting very tired and my appetite decreased during the treatment, but a few days after finishing the fevers started. I had to stay in the hospital for 9 days as a result, which wasn't fun.

5

Patient Review

11/26/2009

Cladribine for Type of Leukemia - Hairy Cell Leukemia

After just one week of this treatment, there was zero leukemia cells found in my bone marrow. No other side effects either, which is amazing. I feel great again!

3.3

Patient Review

7/23/2020

Cladribine for Multiple Sclerosis Symptoms Return then Become Less Severe

It's not the easiest medication to take, in terms of both the physical act and waiting for it to 'kick in'. I don't find that it lasts as long as I would like, but it is effective while working. However, the symptoms come back relatively quickly after it wears off.

3

Patient Review

5/30/2012

Cladribine for Type of Leukemia - Hairy Cell Leukemia

The first treatment was an all-day drip for seven days straight in a hospital setting. The second treatment was five one-hour sessions done consecutively as an outpatient. As side effects, I experienced severe fever, chills, night sweats, fatigue, spleen pain and general discomfort.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about cladribine

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is cladribine used for?

"This medication is used to treat hairy cell leukemia (a cancer of a certain type of white blood cell). It works by slowing or stopping the growth of cancer cells."

Answered by AI

What type of chemo is cladribine?

"How this drug works: Cladribine works by killing cancer cells or by stopping their growth.

Cladribine is an anti-cancer drug that kills cancer cells or prevents their growth."

Answered by AI

How does cladribine work in MS?

"This medication is used to treat relapsing forms of multiple sclerosis. It is not a cure, but it is thought to work by preventing immune system cells from attacking the nerves in the brain and spinal cord. This may help to slow disease progression and reduce the severity of flare-ups."

Answered by AI

Is cladribine a chemotherapy?

"Cladribine is a chemotherapy drug that is mainly used to treat hairy cell leukemia, but it can also be used to treat other types of leukemia."

Answered by AI

Clinical Trials for Cladribine

Image of City of Hope Medical Center in Duarte, United States.

Tafasitamab + Acalabrutinib + Venetoclax for Chronic Lymphocytic Leukemia

18+
All Sexes
Duarte, CA

This phase II trial tests the safety, side effects and how well giving tafasitamab with acalabrutinib and venetoclax works for the treatment of chronic lymphocytic leukemia (CLL)/small cell lymphoma (SLL). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Tafasitamab is a monoclonal antibody that binds to CD19 antigen which is found on the surface of most B cells (a type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantle cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving tafasitamab with acalabrutinib and venetoclax may be safe and effective for treating patients with CLL/SLL.

Phase 2
Waitlist Available

City of Hope Medical Center (+1 Sites)

Benjamin M Heyman

Image of Ohio State University Comprehensive Cancer Center in Columbus, United States.

Nemtabrutinib + Venetoclax for Chronic Lymphocytic Leukemia

18+
All Sexes
Columbus, OH

This phase II trial tests how well nemtabrutinib and venetoclax work in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Nemtabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cells (a type of white blood cell) in cancers such as CLL or SLL at abnormal levels. This may help keep cancer cells from growing and spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Giving nemtabrutinib in combination with venetoclax may kill more cancer cells in patients with CLL or SLL.

Phase 2
Waitlist Available

Ohio State University Comprehensive Cancer Center

Jennifer A Woyach, MD

Merck Sharp & Dohme LLC

Image of Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill in Chapel Hill, United States.

Discontinuing BTK Inhibitors for CLL

18+
All Sexes
Chapel Hill, NC

This Phase II hybrid decentralized multicenter study examines the outcomes of stopping Bruton tyrosine kinase inhibitor (BTKi) therapy in patients with chronic lymphocytic leukemia (CLL) who have remained in remission for at least two years. The primary objective is to determine how long patients remain free from disease progression or death after discontinuing treatment, measured as event free survival. The study also evaluates whether stopping BTKi therapy leads to improvements in quality of life and reductions in treatment related side effects. Researchers will follow patients over time to assess if the cancer returns, whether resistance to therapy develops, and how patients feel during the treatment free period. In addition, the trial will investigate how discontinuing BTKi therapy affects immune function, including whether immune recovery occurs and infection risk decreases. Preliminary data indicate that patients may experience a treatment free interval exceeding two years after stopping therapy, with associated improvements in quality of life. By prospectively evaluating a time limited treatment strategy, this trial aims to determine whether durable disease control can be maintained off therapy while also assessing the resolution of BTKi related adverse events and changes in patient reported outcomes. Overall, the study seeks to determine whether patients can safely discontinue BTKi therapy and potentially restart treatment later if needed, thereby maintaining disease control while reducing the burden of continuous therapy.

Phase 2
Waitlist Available

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Deborah Stephens, DO

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Ruxolitinib for T-Cell Lymphoma

18+
All Sexes
Columbus, OH

This phase II trial tests how well ruxolitinib as a maintenance medication works to prevent relapse and graft-versus-host disease (GVHD) for patients who have undergone stem cell transplantation for T-cell lymphoma. GVHD is a common problem that may occur after a blood stem cell transplant. The "graft" is the donor blood cells that patients get during the transplant. The "host" is the person receiving the cells. GVHD is when the donor graft attacks and damages some of the transplant recipient's tissues. Ruxolitinib is a type of drug called a Janus kinase (JAK) inhibitor which works by decreasing the immune response of cells in the body. It is also a cancer growth blocker that blocks the growth factors that trigger the cancer cells to divide and grow. Ruxolitinib works by blocking a gene, called JAK2, that is important in the production of cancer cells.

Phase 2
Recruiting

Ohio State University Comprehensive Cancer Center

Jonathan Brammer, MD

Incyte Corporation

Image of Optum Medical Group (Rhodes) P.C. in Las Vegas, United States.

Rocbrutinib vs Pirtobrutinib for Chronic Lymphocytic Leukemia

18+
All Sexes
Las Vegas, NV

This is a Phase 3, randomized, open-label, multicenter study comparing rocbrutinib (LP-168) versus pirtobrutinib in adult participants with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received a covalent Bruton's tyrosine kinase inhibitor (cBTKi). Approximately 306 participants will be randomized 1:1 to receive rocbrutinib 200 mg orally once daily or pirtobrutinib 200 mg orally once daily, administered continuously in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria are met. Randomization will be stratified by presence of del(17p)/TP53 mutation (yes/no), reason for discontinuation of prior cBTKi therapy (toxicity vs disease progression), prior exposure to a BCL2 inhibitor (yes/no), and region (United States/China/rest of world). The primary endpoint is progression-free survival (PFS) assessed by an independent review committee (IRC) using iwCLL 2018 criteria for CLL and Lugano 2014 criteria for SLL. Key secondary objectives include overall survival, overall response rate, time-to-event outcomes, and safety/tolerability; exploratory objectives include health-related quality of life and biomarker assessments.

Phase 3
Recruiting

Optum Medical Group (Rhodes) P.C. (+3 Sites)

Newave Pharmaceutical Inc

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DLI-X for Leukemia

Any Age
All Sexes
Tucson, AZ

The primary objective of this proposal is to conduct the first-in-human randomized clinical trial evaluating prophylactic DLI-X (pro-DLI-X) for relapse prevention following matched sibling donor (MSD) or haploidentical (haplo) hematopoietic cell transplantation (HCT) in patients with hematologic malignancies. Additionally, the study aims to assess the safety and efficacy of therapeutic DLI-X (t-DLI-X) compared to t-DLI alone in patients with minimal residual disease (MRD+) or overt relapse post-alloHCT. For patients with CD19-positive lymphoid malignancies, the study will incorporate blinatumomab, while those with myeloid or CD19-negative lymphoid malignancies will receive t-DLI-X or t-DLI alone. We hypothesize that both pro-DLI-X and t-DLI-X, with or without blinatumomab, will demonstrate safety and superior efficacy by enhancing graft-versus-leukemia (GvL) effects mediated by natural killer (NK) cells, γδ T cells, and CD8+ T cells, while maintaining manageable and treatment-responsive graft-versus-host disease (GvHD).

Phase 1
Waitlist Available

The University of Arizona Cancer Center

Emmanuel Katsanis, MD

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Rituximab + Tafasitamab + NK Cells for Non-Hodgkin's Lymphoma

18+
All Sexes
Cleveland, OH

This research study is for people who have relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) that has not responded to two or more lines of therapy. The purpose of this study is to identify the recommended dose of allogeneic NK cells in combination with IL-2, Tafasitamab and Rituximab for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma. NK cells are an investigational (experimental) treatment which means they are not approved by the Food and Drug Administration (FDA). NK cells are a type of lymphocyte that's part of the body's natural immune system, and they can kill cancer cells by creating pores in the cancer cell membranes and inducing apoptosis (programmed cell death). Participants in this study will receive lymphodepleting chemotherapy, as well as Allogeneic NK cells, Tafasitamab and Interleukin-2 (IL-2) by an intravenous (IV) infusion. Participants are expected to complete one cycle, and they may be eligible to complete a second cycle of the same regiment if they have stable disease, partial or complete remission at the end of the first cycle. Participants will be in this study for about 12 months.

Phase 1
Waitlist Available

Case Comprehensive Cancer Center, University Hospitals Seidman Cancer Center (+1 Sites)

Paolo Caimi, MD

Incyte Corporation

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SB-4826 for Non-Hodgkin's Lymphoma

18+
All Sexes
La Jolla, CA

The goal of this clinical trial is to learn what dose of the drug SB-4826 can be given safely in patients with solid tumors and non-Hodgkin lymphomas. This drug will be used alone in patients with solid tumors, and will be used alone or in combination with rituximab in patients with non-Hodgkin lymphomas. The main questions this clinical trial aims to answer are: What is the maximum dose of SB-4826 that can be used safely in patients with solid tumors and non-Hodgkin lymphomas, and will it work? How does SB-4826 work in people with cancer? How is SB-4826 absorbed, broken down, and excreted by the body? Participants will: Take drug SB-4826 twice weekly for up to 1 year; keep a diary of when they take SB-4826 at home; visit the clinic for checkups, tests, and fill out study questionnaires.

Phase 1 & 2
Recruiting

University of California, San Diego

Peter Vu, MD

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