ALLPhase 1/2UPCC 25406NCT00776373
Rapamycin in With High-Dose Etoposide and Cytarabine in Relapsed/Refractory Aggressive Lymphoid Malignancies
A Phase 1/2 study testing Rapamycin and High dose etoposide and cytarabine (HiVAC) in people with ALL and Burkitt's Lymphoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Assess the safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ALL, Burkitt's Lymphoma, Lymphoblastic Leukemia
- What is being tested?
- Rapamycin and High dose etoposide and cytarabine (HiVAC)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19066
About this study
Official title: A Phase I/II, Open-label Single Institution Study Evaluating Rapamycin in Combination With High-dose Etoposide and Cytarabine in Relapsed or Refractory Aggressive Lymphoid Malignancies
Assess the safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies.
- Conditions
- ALL, Burkitt's Lymphoma, Lymphoblastic Leukemia, CML
- Being tested
- Rapamycin, High dose etoposide and cytarabine (HiVAC)
- Keywords
- ALL, Burkitt's Lymphoma, Adult T-Cell leukemia/lymphoma, Lymphoblastic leukemia, CML in lymphoid blast crisis patients, HiVAC, Rapamycin
- Medical subject headings
- Burkitt Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamycinDrug
Rapamycin,by mouth, loading dose followed by a single daily dose for 8 days (dose level 1 = load of 9 mg followed by 3 mg daily doses, dose level 2 = 12 mg with daily doses of 4 mg
High dose etoposide and cytarabine (HiVAC)Drug
Etoposide 500 mg/m2/day IV and Cytarabine 2000 mg/m2/day IV every 24 hours for 4 days.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Rapamycin in combination with High Dose Etoposide and Cytarabine (HiVAC) Receives: Drug: Rapamycin; Drug: High dose etoposide and cytarabine (HiVAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies
Measured: Study completion
Secondary outcomes (2)
Assess and quantify phosphorylation of p70S6 kinase
Measured: Study completion
Whether increased mTOR pathway inhibition correlates with response to therapy with rapamycin and HiVAC
Measured: Study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALLStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Selina Luger, MD, Principal investigator, University of Pennsylvania Abramson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776373
- Sponsor's protocol ID
- UPCC 25406
- Acronym
- UPCC 25406
- Status last verified
- Nov 2025
- First submitted
- 19 Oct 2008
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-label Single Institution Study Evaluating Rapamycin in Combination With High-dose Etoposide and Cytarabine in Relapsed or Refractory Aggressive Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT00776373
- Acronym / sponsor ID
- UPCC 25406 / UPCC 25406
- Conditions
- ALL, Burkitt's Lymphoma, Lymphoblastic Leukemia, CML
- Keywords
- ALL, Burkitt's Lymphoma, Adult T-Cell leukemia/lymphoma, Lymphoblastic leukemia, CML in lymphoid blast crisis patients, HiVAC, Rapamycin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Rapamycin, Drug: High dose etoposide and cytarabine (HiVAC)Rapamycin in combination with High Dose Etoposide and Cytarabine (HiVAC) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RapamycinRapamycin,by mouth, loading dose followed by a single daily dose for 8 days (dose level 1 = load of 9 mg followed by 3 mg daily doses, dose level 2 = 12 mg with daily doses of 4 mg | Drug | Arm 1 |
| High dose etoposide and cytarabine (HiVAC)Etoposide 500 mg/m2/day IV and Cytarabine 2000 mg/m2/day IV every 24 hours for 4 days. | Drug | Arm 1 |
Primary outcome
Safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies
Time frame: Study completion
2 secondary outcomes
Assess and quantify phosphorylation of p70S6 kinase
Time frame: Study completion
Whether increased mTOR pathway inhibition correlates with response to therapy with rapamycin and HiVAC
Time frame: Study completion
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selina Luger, MD principal investigator
University of Pennsylvania Abramson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rapamycin and High dose etoposide and cytarabine (HiVAC) in people with ALL and Burkitt's Lymphoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies (time frame: Study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.