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New drug cocktail aims to tackle tough blood cancers

NCT ID NCT03136146

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This phase II trial is testing a combination of six chemotherapy drugs (clofarabine, etoposide, cyclophosphamide, liposomal vincristine, dexamethasone, and bortezomib) in patients with acute lymphoblastic leukemia, lymphoblastic lymphoma, or related cancers that have come back or not responded to treatment. The study will enroll 42 participants to evaluate side effects and how well the treatment works. The goal is to find a more effective option for these hard-to-treat blood cancers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
clofarabine, etoposide, cyclophosphamide, liposomal vincristine, dexamethasone, bortezomib
What this could lead to
If successful, this could provide a new treatment option for patients with hard-to-treat leukemia or lymphoma that has returned or not responded to prior therapy.
What could go wrong
This is a small, early-phase study (42 participants) focused on safety and response rate. The combination of multiple chemotherapy drugs may cause significant side effects, and it is not yet known if it will improve long-term survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2017

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Relapsed/refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL): * Relapsed and/or refractory Philadelphia negative acute lymphoblastic leukemia or lymphoblastic lymphoma (LL) (Lead-in and Phase II) * Relapsed and/or refractory Philadelphia positive acute lymphoblastic leukemia, Burkitt leukemia/lymphoma or "double-hit" leukemia/lymphoma (phase II only) * At least 21 days elapsed from prior systemic chemotherapy (at least 14 days elapsed from prior systemic chemotherapy in the setting of rapidly progressive disease without significant residual extramedullary toxicity). Hydroxyurea and dexamethasone permitted up to approximately 24 hours prior to the start of therapy. Interruption of tyrosine kinase inhibitor (TKI) not required in Ph positive ALL subset * Age older than 15 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 3 (There may be certain patients with performance status \[PS\] 3 in the context of rapidly proliferative/refractory ALL who would benefit from this regimen. We don't want to exclude such patients who may derive benefit from this salvage regimen) * Serum bilirubin =\< 1.5 mg/dL * Serum glutamate pyruvate transaminase (SGPT) =\< 3 x upper limit normal (ULN), with exception for Gilbert's syndrome * Estimated creatinine clearance or GFR (glomerular filtration rate) \>= 50 mL/min * Signed informed consent Exclusion Criteria: * Active \>= grade 3 peripheral neuropathy * Active hepatic graft-versus-host disease * Known positivity for hepatitis B or C * Pregnancy * Breast feeding

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • M D Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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