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Promising combo for tough blood cancers halted early — only 4 patients enrolled

NCT ID NCT00776373

Disease control Sponsor: Abramson Cancer Center at Penn Medicine Source: ClinicalTrials.gov ↗

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding rapamycin to high-dose chemotherapy could help people with aggressive blood cancers (like certain leukemias and lymphomas) that had returned or not responded to prior treatment. Only 4 adults aged 18–65 took part before the study was stopped early. The goal was to check safety and whether the combination could control the disease, but results are limited due to the small size.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

4 people

The number who actually took part.

Start date

Jan 2007

Finished

Dec 2009

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 to 65 years

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: * Advanced lymphoid leukemia (primary refractory ALL; Relapsed ALL; CML in lymphoid accelerated phase or blast crisis; relapsed or refractory Burkitt's lymphoma; relapsed or refractory T-cell adult leukemia/lymphoma; relapsed or refractory lymphoblastic lymphoma * \>= 18 and \<= 65 years of age ECOG performance status 0, 1 Life expectancy \>= 4 weeks Able to consume oral medication Required initial laboratory values: Creatinine \<= 2.0mg/dL, total or direct bilirubin \<= 1.5 mg/dL, SGPT(ALT) \<=ULN, glucose \< 200 mg/dL, negative pregnancy test for women with child bearing potential Exclusion Criteria: * Subjects must not be receiving any chemotherapy agents (except Hydroxyurea) * Subjects must not have received high-dose Ara-C within 6 months of relapse * Subjects must not be receiving growth factors, except for erythropoietin * No currently active second malignancy other than non-melanoma skin cancers * No subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, MI within the last 6 months or serious uncontrolled cardiac arrhythmia * Subjects taking Carbamazepine, Rifabutin, Rifampin, Rifapentine, St. John's wort, Clarithromycin, Cyclosporine, Diltiazem, Erythromycin, Telithromycin, Verapamil, Tacrolimus * Known HIV positivity or AIDS-related illness * Evidence of cerebellar dysfunction or prior history of cerebellar dysfunction with Ara-C administration * Pregnant or lactating * Uncontrolled infection * Taking fluconazole, voriconazole, itraconazole and ketoconazole currently or within one week of study entry

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia adult T-cell leukemia/lymphoma blast phase chronic myelogenous leukemia, BCR-ABL1 positive Burkitt lymphoma chronic myelogenous leukemia, BCR-ABL1 positive lymphoblastic lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

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

ALL Burkitt's lymphoma CML Lymphoblastic leukemia

Contacts and locations

Locations

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19066, United States

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