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Old drugs, new hope: combo tackles relapsed leukemia after transplant

NCT ID NCT02312102

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested a combination of two chemotherapy drugs, bortezomib (Velcade) and lenalidomide (Revlimid), in 22 adults whose acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) had returned after a stem cell transplant. The main goal was to find the safest dose and see if the combo could reduce cancer cells. While promising, the study is small and early, so more research is needed.

What this could mean

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

Active substance
bortezomib (Velcade) and lenalidomide (Revlimid)
What this could lead to
If successful, this combination could offer a new treatment option for people whose AML or MDS has returned after a stem cell transplant.
What could go wrong
This is a very early, small Phase 1 trial with only 22 participants, so results may not apply broadly. The drugs also have known side effects like low blood counts and nerve damage.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

22 people

The number who actually took part.

Started

Feb 2015

Finished

Oct 2024

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

18 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: * Participants must meet the following criteria on screening examination to be eligible to participate in the study: * A diagnosis of recurrent, persistent, or progressive acute myelogenous leukemia (AML), defined as \>= 5% blasts in a patient with known prior history of AML, or recurrent, persistent, or progressive myelodysplastic syndrome (MDS) according to WHO criteria. * Must have undergone an allogeneic SCT (regardless of stem cell source) * Patients must be 18 years or older * Able to adhere to study schedule and other protocol requirements * Must be off all immunosuppressive medications (except prednisone) for at least 2 weeks prior to study entry. * Must be on less than 21 mg of oral prednisone daily for GVHD * ECOG performance status 0-2 (see Appendix 2) * Participants must have the following organ function all within 21 days prior to enrollment * Total bilirubin ≤ 2.0 mg/dl unless due to underlying conjugation disease such as Gilbert's * ALT and AST ≤ 3X the upper limit of normal * Creatinine \< 2.0 mg/dl * Patients may receive hydroxyurea or leukopheresis as necessary * Patients must give voluntary written informed consent and HIPA authorization before performance of any study-related procedure not part of normal medical care with the understanding that consent maybe withdrawn by the subject at any time without prejudice to future medical care. * All previous cancer therapy including donor lymphocyte infusions must have been discontinued at least 2 weeks prior to treatment in this study. * All study participants must be registered in the RevREMS® program and be willing and able to comply with the requirements of REMS® program. * Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program. Exclusion Criteria: * Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study. * Ejection fraction \< 40% obtained by either MUGA or echocardiogram * Patients who had had a myocardial infarction within 6 months of enrollment or have New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant. * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the consent form. * Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at an unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * Patients with major surgery within 28 days prior to trial enrollment * Patients with greater than or equal to grade 2 peripheral neuropathy or active herpes infection * Patients with ≥ grade 3 acute graft-versus-host disease are excluded from the study * Patients with moderate or severe chronic graft-versus host requiring more than 20 mg of oral prednisone therapy are excluded from the study. * Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cirrhosis, chronic obstructive or restrictive pulmonary disease, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia * Patients with any serious or medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol * Female subject is pregnant or breast-feeding. Lactating females must agree not to breastfeed while taking lenalidomide. * Patient has received an investigational drug within 14 days of enrollment * Known hypersensitivity to thalidomide or lenalidomide * Known hypersensitivity to Velcade, boron, or mannitol * The development of erythema nodosum as characterized by desquamating rash while taking thalidomide or similar drugs * Concurrent use of other anti-cancer agents or treatment * Known positive for HIV * Diagnosed or treated for a non-hematologic malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy. * Radiation therapy within 3 weeks before randomization. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.

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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.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.