Experimental drug RAD001 tested for tough leukemias and lymphomas
NCT ID NCT00081874
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested the drug RAD001 (everolimus) in 29 patients with relapsed or hard-to-treat blood cancers like leukemia, lymphoma, and myelofibrosis. The goal was to find the safest highest dose and see if it helps control the disease. It was a small early-phase trial at a single cancer center.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RAD001 (everolimus, Afinitor)
- What this could lead to
- If successful, this could point toward a new treatment option for patients with hard-to-treat blood cancers.
- What could go wrong
- This is an early-phase trial with only 29 participants, so results may not apply broadly. The drug may cause side effects or fail to shrink tumors.
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
-
29 people
The number who actually took part.
- Start date
-
Apr 2004
- Finished
-
Sep 2006
- 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
-
Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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 Hide 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: 1. Patients with advanced, relapsed or refractory: acute leukemias (AML, ALL), MDS, CMML in transformation with greater than or equal to 10% peripheral blood/bone marrow blasts, CML in blastic phase, agnogenic myeloid metaplasia (AMM), CLL, T-cell leukemia, or mantle cell lymphoma. 2. Serum bilirubin \<= 2 mg/dL, SGOT or SGPT \< 3 upper limit of normal, serum creatinine \<= 2 mg/dL, unless considered due to organ leukemic involvement or Gilbert's syndrome 3. The effects of RAD001 on the developing human fetus are unknown. For this reason and because inhibitors of mRNA translation are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 4. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients who have had cytotoxic chemotherapy (other than hydroxyurea or corticosteroids) or radiotherapy within 7 days prior to entering the study. 2. Patients may not be receiving any other cytotoxic investigational agents. 3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to RAD001. RAD001 must not be administered to patients with known hypersensitivity to everolimus, sirolimus or to any of its excipients. Excipients include butylated hydroxytoluene, magnesium stearate, hydroxypropylmethyl-cellulose, crospovidone, and lactose. 4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 5. Pregnant women are excluded from this study because RAD001 has a potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with RAD001, breastfeeding should be discontinued if the mother is treated with RAD001.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute lymphocytic leukemia are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can adding venetoclax make donor stem cell transplants safer for High-Risk blood cancers?
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Half-Matched stem cells tested as cure for myelofibrosis
- Triple drug combo targets mantle cell lymphoma
- Can starting anemia drug sooner keep MDS patients off transfusions?
- Blood cancer registry tracks thousands to map disease course