11-001 Consent and Eligibility Cheat Sheet
1. Only investigators listed on the 1572 can consent patients to 11-001.
2. Template for note documenting Informed Consent Discussion (Mandatory)
It is essential that you document your informed consent discussion and that the patient
meets all eligibility requirements to enroll on the trial in a note in the patient’s medical
record on the day that the informed consent is obtained. The signed informed consent and
the completed eligibility checklist are not sufficient documentation. The templated note
below contains the required elements of the note you should put into the patient’s medical
record.
Cut and paste the following into your note on the day you obtain informed consent. Please
make sure to update name of patient/diagnosis, length of discussion, etc in your note.
Consent and Eligibility Documentation (to be included in note on day of consent):
I met with [name of patient/parents] for approximately ____ minutes to discuss participation in a
Randomized Study of Intravenous Calaspargase Pegol (SC-PEG asparaginase) and Intravenous Oncaspar in
Children and Adolescents with Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma (DFCI
Protocol 11-001). The research was fully explained to the [name of patient/parents]. Risks of the agents
used in the trial, as detailed in the informed consent document, were explained in great detail and
alternative non-research treatment options were also presented. The [name of patient/parents] verbalized
understanding of the risks and benefits of the study. [name of patient/parents] were given time to ask any
questions about the study and had all of [choose one: his/her/their] questions regarding the study answered.
They indicated their understanding that participation is voluntary and that they can withdraw consent/assent
at any time. At the end of the discussion, [name of patient/parents] indicated that they wished to participate
in the trial. The informed consent document was signed today and [name of patient/parents] was/were
given a copy of the signed consent form.
The participant has a confirmed diagnosis of [choose one: acute lymphoblastic leukemia or lymphoblastic
lymphoma]. They have not received corticosteroids for more than a 7 day period within the last 4 weeks or
more than 28 days in the last 6 months. The participant has not received any chemotherapy or radiotherapy
for a previous malignancy. [Choose one: He/She] has not previously received anti-neoplastic agents,
including methotrexate, 6-mercaptopurine, 6-thioguanine, vincristine, cyclophosphamide, IV cytarabine or
any anthracycline, for any reason. The participant is currently not receiving any other investigational
agents. The participant does not have any severe and/or uncontrolled intercurrent illness, is not known to be
HIV positive at time of enrollment, and has no history of previous malignancy that required treatment other
than surgery in the past 5 years.
Day 18 Optional Bone Marrow Consent Documentation
If Participant/Parent Agrees to Day 18 Marrow Aspirate:
I met with [name of participant/parents] for approximately_____ minutes to discuss the optional Day 18
bone marrow aspirate that is part of the protocol "A Randomized Study of Intravenous Calaspargase Pegol
(SC-PEG asparaginase) and Intravenous Oncaspar in Children and Adolescents with Acute Lymphoblastic
Leukemia or Lymphoblastic Lymphoma (DFCI Protocol 11-001)". The research was fully explained to
the [name of participant/parents]. Risks of the bone marrow aspirate, as detailed in the informed consent
document, were explained in detail and the option to not participate was presented. The
[participant/parents] verbalized understanding of the risks and benefits of the optional bone marrow
aspirate. [name of patient/parents] were given time to ask any questions about the study and had all of
[choose one: his/her/their] questions regarding the study answered. At the end of the discussion, [name of
participant/parents] indicated that they agreed to participate. They indicated their understanding that
participation is voluntary and that they can withdraw consent/assent at any time. The informed consent
document was signed today and [the participant/parents] was/were given a copy of the signed consent form.
If Participant/Parent Does Not Agree to Day 18 Marrow Aspirate: Please document in your chart note
that the patient declined.
Change to VHR Consent Documentation (to be included in note on day of consent):
If Participant/Parent Agrees to consent to the VHR arm of the protocol:
I met with [name of participant/parents] for approximately _____________ minutes to discuss the
participation in the Very High Risk arm of DFCI protocol 11001: a Randomized Study of Intravenous
Calaspargase Pegol (SC-PEG asparaginase) and Intravenous Oncaspar in Children and Adolescents with
Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma. We indicated that based on the [choose
one: high MRD level/chromosomal abnormalities/ETP phenotype], we recommended that [name of
patient/parents] be changed to the very high risk arm of Protocol 11-001. I detailed the treatment on the
Very High Risk Arm, emphasizing the differences between the [name of participant]’s current treatment
arm and the very high risk arm on the protocol. We discussed that, on the very high risk arm, [name of
patient/parents] would receive 2 additional cycles of consolidation chemotherapy. The first would include
cyclophosphamide, low-dose ara-C, and 6-MP (as well as a dose of intrathecal methotrexate), and the
second cycle would include high-dose cytarabine, dexamethasone, and etoposide. [name of patient/parents]
would then proceed to the CNS and Consolidation II phases of treatment, which would include
doxorubicin every 3-weeks through the Consolidation II phase up to a cumulative dose of 300 mg/m2.
Dexrazoxane would be administered prior to each dose of doxorubicin as a cardio-protectant agent. I
explained that these phase would also include 10 cycles with high dose dexamethasone and that cranial
radiation would be administered during the CNS phase. I explained that the total duration of treatment
would continue to be 24 months from the date of complete remission, and that the continuation phase of
treatment would be the same as initially planned. Alternative treatment approaches were discussed. The
[name of patient/parents] verbalized understanding of the risks and benefits of the study. [name of
patient/parents] were given time to ask any questions about the study and had all of [choose one:
his/her/their] questions regarding the study answered. They indicated their understanding that participation
is voluntary and that they can withdraw consent/assent at any time. At the end of the discussion, [name of
patient/parents] indicated that they agreed to change in risk group to the Very High Risk group. The
informed consent document was signed today and [name of patient/parents] was/were given a copy of the
signed consent form.
If Participant/Parent Does Not Agree to consent to the VHR arm of the protocol: Please document in
your chart note that the patient declined and the patient will need to be taken off treatment.
Start of CNS Phase Optional Bone Marrow Consent Documentation (for T-cell ALL
patients who are not VHR)
If Participant/Parent Agrees to Start of CNS Marrow Aspirate:
I met with [name of participant/parents] for approximately_____ minutes to discuss the optional bone
marrow aspirate at the start of the CNS phase that is part of the protocol "A Randomized Study of
Intravenous Calaspargase Pegol (SC-PEG asparaginase) and Intravenous Oncaspar in Children and
Adolescents with Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma (DFCI Protocol 11-001)".
The research was fully explained to the [name of participant/parents]. Risks of the bone marrow aspirate,
as detailed in the informed consent document, were explained in detail and the option to not participate was
presented. The [participant/parents] verbalized understanding of the risks and benefits of the optional bone
marrow aspirate. [name of patient/parents] were given time to ask any questions about the study and had
all of [choose one: his/her/their] questions regarding the study answered. At the end of the discussion,
[name of participant/parents] indicated that they agreed to participate. They indicated their understanding
that participation is voluntary and that they can withdraw consent/assent at any time. The informed consent
document was signed today and [the participant/parents] was/were given a copy of the signed consent form.
If Participant/Parent Does Not Agree to Start of CNS Phase Marrow Aspirate: Please document in
your chart note that the patient declined.
End of Treatment Optional Bone Marrow Consent Documentation
If Participant/Parent Agrees to End of Treatment Marrow Aspirate:
I met with [name of participant/parents] for approximately_____ minutes to discuss the optional end of
treatment bone marrow aspirate that is part of the protocol "A Randomized Study of Intravenous
Calaspargase Pegol (SC-PEG asparaginase) and Intravenous Oncaspar in Children and Adolescents with
Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma (DFCI Protocol 11-001)". The research
was fully explained to the [name of participant/parents]. Risks of the bone marrow aspirate, as detailed in
the informed consent document, were explained in detail and the option to not participate was presented.
The [participant/parents] verbalized understanding of the risks and benefits of the optional bone marrow
aspirate. [name of patient/parents] were given time to ask any questions about the study and had all of
[choose one: his/her/their] questions regarding the study answered. At the end of the discussion, [name of
participant/parents] indicated that they agreed to participate. They indicated their understanding that
participation is voluntary and that they can withdraw consent/assent at any time. The informed consent
document was signed today and [the participant/parents] was/were given a copy of the signed consent form.
If Participant/Parent Does Not Agree to the End of Treatment Marrow Aspirate: Please document in
your chart note that the patient declined.