Non-hodgkin LymphomaPhase 1NCT03713580
Venetoclax in Combination With BEAM Conditioning Regimen for ASCT in Non-Hodgkin Lymphoma
A Phase 1 study testing Venetoclax in people with Non-hodgkin Lymphoma, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial summary
The purpose of this study is to determine the correct dose and safety of adding a new cancer drug, Venetoclax, to a standard combination of chemotherapy drugs used prior to Autologous stem cell transplant (ASCT) in participants with Non-Hodgkin Lymphoma (NHL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-hodgkin Lymphoma
- What is being tested?
- Venetoclax
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Mar 2019to 7 Nov 2025
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed Non-Hodgkin Lymphoma (NHL) including T-cell lymphomas, after at least one prior systemic treatment regimen such as CHOP, R-CHOP, CHOEP, R-EPOCH, R-HyperCVAD, BR, VR-CAP alternating with rituximab and cytarabine, etc.
- Patients in complete or partial remission, or in the case of patients with stable or refractory disease are undergoing autologous transplantation because it has been recommended by their treating physician as representing their best treatment option.
- ECOG Performance status ≤ 2 at time of consent [See Appendix I].
- Patients must have normal organ and marrow function as defined below:
- Hemoglobin ≥ 8.0 g/dl
- Absolute neutrophil count ≥ 1,000/mcL
Show all 43Show fewer
- Platelet count ≥ 75,000/mcL
- Total bilirubin ≤ 1.5X the upper limit of normal (ULN) unless a known history of impaired bilirubin conjugation such as Gilbert's.
- AST (SGOT) ≤ 2.5 X institutional ULN
- ALT (SGPT) ≤ 2.5 X institutional ULN
- Patients must have a calculated serum creatinine clearance > 50 mL/min using Cockcroft-Gault calculation or based on 24-hour urine collection performed within 7 days prior to treatment.
- Cardiac ejection fraction >45% or clearance by PI or Cardiology
- DLCO of >45% predicted or clearance by PI or Pulmonology
- Specific guidelines will be followed regarding inclusion of NHL based on Hepatitis B serological testing as follows:
- HBsAg negative, HBcAb negative, HBsAb negative patients are eligible.
- HBsAg negative, HBcAb negative, HBsAb positive patients are eligible.
- Patients who test positive for HBsAg are ineligible.
- Patients with HBsAg negative, but HBcAb positive (regardless of HBsAb status) should have a HBV DNA testing performed and protocol eligibility determined as follows:
- If HBV DNA is positive, the patient is ineligible.
- If HBV DNA is negative, the patient may be included but must undergo HBV DNA PCR testing monthly x 3 months beginning from the start of treatment
- Female patients who are not surgically sterile or postmenopausal (for at least 1year) must practice at least one of the following methods of birth control throughout the duration of study participation and for at least 30 days after study treatment:
- Total abstinence from sexual intercourse
- A vasectomized partner
- Hormonal contraceptives (oral, parenteral, vaginal ring, or transdermal) that started at least 3months prior to study drug administration
- Double-barrier method (condom+diaphragm or cervical cup with spermicidal contraceptive sponge, jellies, or cream)
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
- Exclusion Criteria: The presence of any of the following will exclude a patient from study enrollment:
- Patients who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
- Prior treatment toxicities have not resolved to ≤ Grade 2 according to NCI CTCAE Version 5.0 (except clinically unrelated toxicities such as alopecia or peripheral neuropathy).
- Patients receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Venetoclax or other agents used in this study.
- Patients with 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.
- Patients who are pregnant or breastfeeding will be excluded from this study because carmustine, etoposide, cytarabine, and melphalan are chemotherapeutic agents with the 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 carmustine, etoposide, cytarabine, and melphalan, breastfeeding should be discontinued if the mother is treated with these agents. These potential risks may also apply to other agents used in this study.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Venetoclax. In addition, these patients are at increased risk of lethal infections when treated with marrow suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. HIV testing prior to enrollment is not required for screening but strongly encouraged for patients with no documented prior HIV assessment.
- Malabsorption syndrome or other condition that precludes enteral route of Venetoclax administration
- Patients with metastatic solid tumor malignancies. Patients who have early stage solid tumors and have completed curative treatment are eligible at the discretion of the primary investigator. Patients with unresected but localized stage prostate cancer or other carcinomas in situ that are undergoing observation are also allowed. Patients with transformed lymphoma and/or underlying indolent lymphoproliferative disorder are allowed at the discretion of the investigator.
- Major surgery, other than diagnostic surgery, within 2 weeks.
- Medical condition requiring chronic use of high dose systemic corticosteroids (i.e., doses of prednisone higher than 10 mg/day or equivalent). Brief (<15 days) treatment with glucocorticoids (prednisone 100 mg by mouth daily, or equivalent) is acceptable.
- Patients with chronic use of moderate or strong CYP3A4 modulators (inhibitor or inducer) or use of a P-gp inhibitor, or a P-gp substrate with a narrow therapeutic index are prohibited. A washout period of 7 days is required prior to Venetoclax dosing if a prohibited medication is discontinued. Lists including medications or substances known or with the potential to interact with the specific CYP3A4 isoenzymes and P-gp are provided in Appendix II.
- Concomitant medications that fall into the categories below could potentially lead to adverse reactions and should be considered cautionary (except where noted). Medications and cautionary medications that fall into the categories within this section can be found at http://medicine.iupui.edu/clinpharm/ddis/main-table. If a potential study patient is taking any of the medications in the categories described below, the investigator will assess and document the use of medications known or suspected to fall in the following medication categories:
- Moderate/Weak CYP3A inducers such as efavirenz and oxcarbazepine.
- CYP2C8 substrates such as thiazolidinediones (glitazones) and select statins (because of expected inhibition of the metabolism of CYP2C8 substrates by Venetoclax).
- CYP2C9 substrates such as tolbutamide (because of expected inhibition of the metabolism of CYP2C9 substrates by Venetoclax). It is recommended to exclude CYP2C9 substrates with a narrow therapeutic index such as phenytoin.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: A Phase I Trial of Venetoclax in Combination With BEAM Conditioning Regimen for Autologous Stem Cell Transplantation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
The purpose of this study is to determine the correct dose and safety of adding a new cancer drug, Venetoclax, to a standard combination of chemotherapy drugs used prior to Autologous stem cell transplant (ASCT) in participants with Non-Hodgkin Lymphoma (NHL). In this study, Venetoclax will be added to BEAM (BCNU or carmustine, etoposide, cytarabine or ara-c, and melphalan). All NHL participants are admitted for conditioning chemotherapy which is given prior to the infusion of stem cells.
Venetoclax is a new anti-cancer drug that works by targeting a protein (known as the Bcl-2 protein). By inhibiting or "blocking" this protein, a downstream cascade occurs which results in cancer cells to die. Adding Venetoclax to the standard BEAM conditioning chemotherapy with autologous stem cell transplant is believed to increase the chance of remission. Venetoclax is Food and Drug Administration (FDA) approved for participants with chronic lymphocytic leukemia (CLL). However, Venetoclax is investigational for this study because it is not yet approved for use in participants with NHL or in combination with BEAM chemotherapy.
Read the detailed description
The primary objective of this study is to establish the safety of V-BEAM conditioning regimen prior to autologous stem cell transplant in order to identify the recommended phase II dose (RPD2). This study will also seek to compare time to neutrophil engraftment and time to platelet engraftment of participants who receive V-BEAM and ASCT, compared to historical controls and among cohorts. And finally, it will determine the Progression Free Survival (PFS) and Overall Survival (OS) of V+BEAM followed by ASCT relative to historical controls of BEAM alone followed by ASCT.
This will be a single-institution, open label, phase I study designed to evaluate the safety of this combination. The target population will be participants with NHL who are eligible for ASCT. Dose escalation will proceed using a standard 3 + 3 design with 5 dose levels, a minimum of 6 participants and a maximum of 30 participants will be required to identify the RP2D. If a participant does not take all scheduled doses of Venetoclax according to his/her cohort, the participant will be replaced because he/she has not taken enough drug to confirm safety at that dose level.
Once the conditioning regimen has been delivered and autologous stem cells have been infused there is no further disease-directed treatment as part of this protocol. In accordance with routine practice the bone marrow transplant program at the Cleveland Clinic, participants receive supportive care and follow-up until disease relapse or death. In the absence of treatment delays during the conditioning regimen due to adverse events, participants will remain on study for 24 months or until one of the following criteria applies:
- Disease progression
- Intercurrent illness that prevents further administration of treatment
- The investigator considers it, for safety reasons, to be in the best interest of the participant.
- General or specific changes in the participant's condition rendering the participant unacceptable for further treatment in the judgment of the investigator.
- Participants decision to withdraw from treatment (partial consent) or from the study (full consent)
- Pregnancy during the course of the study for a child-bearing participant
- Death, or
- Sponsor reserves the right to temporarily suspend or prematurely discontinue this study.
Participants will be followed for toxicity for 24 months after hospital discharge or until a protocol approved outcome. The first 3 months will be at the treating center and continued recommended follow-up should be at a minimum of 6 months, 12 months, 18 months and 24 months after hospital discharge or as clinically appropriate according to local practices.
The clinical course of each event will be followed until resolution, stabilization, or until it has been determined that the study treatment or participation is not the cause.
Serious adverse events that are still ongoing at the end of the study period will necessitate follow-up to determine the final outcome. Any serious adverse event that occurs after the study period and is considered to be possibly related to the study treatment or study participation will be recorded and reported immediately.
- Conditions
- Non-hodgkin Lymphoma
- Being tested
- Venetoclax
- Keywords
- Autologous stem cell transplant (ASCT), Venetoclax
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Adding Venetoclax, a BCL-2 inhibitor, to standard high dose therapy prior to autologous stem cell transplant (ASCT).
Venetoclax is a novel, orally bioavailable, small-molecule B-cell lymphoma-2 (Bcl-2) family inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax+BEAM x 1 cycle prior to ASCT | Experimental | Venetoclax dose escalation cohorts + BEAM (Carmustine, Etoposide, Cytarabine, Melphalan) begin with dose level 1 (800mg on Day -7 and Day -6). The dosing cohorts are escalated in a 3 + 3 design but with increasing duration instead of increasing dosage.
Carmustine 300 mg/m2 by IV over 2 hours on Day -7.
Etoposide 100 mg/m2 by IV over 6 hours daily for 4 consecutive days, Day-6 through Day-3.
Cytarabine 200 mg/m2 by IV over 2 hours every 12 hours for 3 consecutive days, Day-6 through Day-4.
Melphalan 140 mg/m2 by IV over 30 minutes or IV push once on Day -2.
Following V+BEAM therapy, participants will receive Autologous Stem Cell Transplant (ASCT): infusion of previously collected autologous stem cells and supportive care per institutional guidelines Receives: Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of intervention as defined by hematopoietic non-engraftment (failure of either ANC engraftment or platelet engraftment).
Safety of intervention will be measured by the effect on hematologic engraftment (engraftment Dose Limiting Toxicity DLT). This includes failure of absolute neutrophil count (ANC) engraftment OR platelet engraftment.
- Failure of ANC engraftment which is defined as failure to engraft by day 15.
OR
- Failure of platelet engraftment which is defined as failure to engraft by day 30.
Measured: Up to 30 days after Autologous Stem Cell Transplant (ASCT)
Secondary outcomes (4)
Time to neutrophil engraftment
Compare time to neutrophil engraftment of patients who receive V-BEAM followed by ASCT, compared to historical controls and among cohorts.
Measured: 24 months after hospital discharge
Time to platelet engraftment
Compare time to platelet engraftment of patients who receive V-BEAM followed by ASCT, compared to historical controls and among cohort.
Measured: 24 months after hospital discharge
Progression-free survival (PFS)
Determine the Progression Free Survival (PFS) of V+BEAM followed by ASCT relative to historical controls of BEAM alone followed by ASCT.
PFS is defined as the time from entry onto study until lymphoma progression or death from any cause. PFS reflects tumor growth and, therefore, occurs prior to the endpoint of overall survival.
Measured: 24 months after hospital discharge
Overall Survival (OS)
Determine the Overall Survival (OS) of V+BEAM followed by ASCT relative to historical controls of BEAM alone followed by ASCT.
Measured: 24 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start12 Mar 2019
- Primary completion7 Dec 2023
- Study completion7 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Winter, MD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713580
- Sponsor's protocol ID
- CASE2418
- Status last verified
- Jul 2026
- First submitted
- 5 Oct 2018
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Venetoclax in Combination With BEAM Conditioning Regimen for Autologous Stem Cell Transplantation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT03713580
- Acronym / sponsor ID
- CASE2418
- Conditions
- Non-hodgkin Lymphoma
- Keywords
- Autologous stem cell transplant (ASCT), Venetoclax
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Nov 2025 (actual)
- First posted
- 19 Oct 2018 (actual)
- 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.
The purpose of this study is to determine the correct dose and safety of adding a new cancer drug, Venetoclax, to a standard combination of chemotherapy drugs used prior to Autologous stem cell transplant (ASCT) in participants with Non-Hodgkin Lymphoma (NHL). In this study, Venetoclax will be added to BEAM (BCNU or carmustine, etoposide, cytarabine or ara-c, and melphalan). All NHL participants are admitted for conditioning chemotherapy which is given prior to the infusion of stem cells.
Venetoclax is a new anti-cancer drug that works by targeting a protein (known as the Bcl-2 protein). By inhibiting or "blocking" this protein, a downstream cascade occurs which results in cancer cells to die. Adding Venetoclax to the standard BEAM conditioning chemotherapy with autologous stem cell transplant is believed to increase the chance of remission. Venetoclax is Food and Drug Administration (FDA) approved for participants with chronic lymphocytic leukemia (CLL). However, Venetoclax is investigational for this study because it is not yet approved for use in participants with NHL or in combination with BEAM chemotherapy.
Detailed description
The primary objective of this study is to establish the safety of V-BEAM conditioning regimen prior to autologous stem cell transplant in order to identify the recommended phase II dose (RPD2). This study will also seek to compare time to neutrophil engraftment and time to platelet engraftment of participants who receive V-BEAM and ASCT, compared to historical controls and among cohorts. And finally, it will determine the Progression Free Survival (PFS) and Overall Survival (OS) of V+BEAM followed by ASCT relative to historical controls of BEAM alone followed by ASCT.
This will be a single-institution, open label, phase I study designed to evaluate the safety of this combination. The target population will be participants with NHL who are eligible for ASCT. Dose escalation will proceed using a standard 3 + 3 design with 5 dose levels, a minimum of 6 participants and a maximum of 30 participants will be required to identify the RP2D. If a participant does not take all scheduled doses of Venetoclax according to his/her cohort, the participant will be replaced because he/she has not taken enough drug to confirm safety at that dose level.
Once the conditioning regimen has been delivered and autologous stem cells have been infused there is no further disease-directed treatment as part of this protocol. In accordance with routine practice the bone marrow transplant program at the Cleveland Clinic, participants receive supportive care and follow-up until disease relapse or death. In the absence of treatment delays during the conditioning regimen due to adverse events, participants will remain on study for 24 months or until one of the following criteria applies:
- Disease progression
- Intercurrent illness that prevents further administration of treatment
- The investigator considers it, for safety reasons, to be in the best interest of the participant.
- General or specific changes in the participant's condition rendering the participant unacceptable for further treatment in the judgment of the investigator.
- Participants decision to withdraw from treatment (partial consent) or from the study (full consent)
- Pregnancy during the course of the study for a child-bearing participant
- Death, or
- Sponsor reserves the right to temporarily suspend or prematurely discontinue this study.
Participants will be followed for toxicity for 24 months after hospital discharge or until a protocol approved outcome. The first 3 months will be at the treating center and continued recommended follow-up should be at a minimum of 6 months, 12 months, 18 months and 24 months after hospital discharge or as clinically appropriate according to local practices.
The clinical course of each event will be followed until resolution, stabilization, or until it has been determined that the study treatment or participation is not the cause.
Serious adverse events that are still ongoing at the end of the study period will necessitate follow-up to determine the final outcome. Any serious adverse event that occurs after the study period and is considered to be possibly related to the study treatment or study participation will be recorded and reported immediately.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venetoclax+BEAM x 1 cycle prior to ASCT | Experimental | Drug: VenetoclaxVenetoclax dose escalation cohorts + BEAM (Carmustine, Etoposide, Cytarabine, Melphalan) begin with dose level 1 (800mg on Day -7 and Day -6). The dosing cohorts are escalated in a 3 + 3 design but with increasing duration instead of increasing dosage. Carmustine 300 mg/m2 by IV over 2 hours on Day -7. Etoposide 100 mg/m2 by IV over 6 hours daily for 4 consecutive days, Day-6 through Day-3. Cytarabine 200 mg/m2 by IV over 2 hours every 12 hours for 3 consecutive days, Day-6 through Day-4. Melphalan 140 mg/m2 by IV over 30 minutes or IV push once on Day -2. Following V+BEAM therapy, participants will receive Autologous Stem Cell Transplant (ASCT): infusion of previously collected autologous stem cells and supportive care per institutional guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (43 listed)
- Patients must have histologically confirmed Non-Hodgkin Lymphoma (NHL) including T-cell lymphomas, after at least one prior systemic treatment regimen such as CHOP, R-CHOP, CHOEP, R-EPOCH, R-HyperCVAD, BR, VR-CAP alternating with rituximab and cytarabine, etc.
- Patients in complete or partial remission, or in the case of patients with stable or refractory disease are undergoing autologous transplantation because it has been recommended by their treating physician as representing their best treatment option.
- ECOG Performance status ≤ 2 at time of consent [See Appendix I].
- Patients must have normal organ and marrow function as defined below:
- Specific guidelines will be followed regarding inclusion of NHL based on Hepatitis B serological testing as follows:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| VenetoclaxAdding Venetoclax, a BCL-2 inhibitor, to standard high dose therapy prior to autologous stem cell transplant (ASCT). Venetoclax is a novel, orally bioavailable, small-molecule B-cell lymphoma-2 (Bcl-2) family inhibitor. | Drug | Venetoclax+BEAM x 1 cycle prior to ASCT |
Primary outcome
Safety of intervention as defined by hematopoietic non-engraftment (failure of either ANC engraftment or platelet engraftment).
Time frame: Up to 30 days after Autologous Stem Cell Transplant (ASCT)
Safety of intervention will be measured by the effect on hematologic engraftment (engraftment Dose Limiting Toxicity DLT). This includes failure of absolute neutrophil count (ANC) engraftment OR platelet engraftment. • Failure of ANC engraftment which is defined as failure to engraft by day 15. OR • Failure of platelet engraftment which is defined as failure to engraft by day 30.
4 secondary outcomes
Time to neutrophil engraftment
Time frame: 24 months after hospital discharge
Time to platelet engraftment
Time frame: 24 months after hospital discharge
Progression-free survival (PFS)
Time frame: 24 months after hospital discharge
Overall Survival (OS)
Time frame: 24 months after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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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.
Allison Winter, MD principal investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Venetoclax in people with Non-hodgkin Lymphoma, run by Case Comprehensive Cancer Center at 2 sites 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 43 inclusion and 0 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: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of intervention as defined by hematopoietic non-engraftment (failure of either ANC engraftment or platelet engraftment). (time frame: Up to 30 days after Autologous Stem Cell Transplant (ASCT)). 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 30 Jul 2026.